
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Proposed Rules]
[Pages 71415-71427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807

[Docket No. FDA-2016-N-2491]
RIN 0910-AG79


Electronic Submission of Labeling for Certain Home-Use Medical 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
implement provisions of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) to require electronic submission of the device label and 
package insert of certain home-use devices when these devices are 
listed with FDA. FDA plans to make this device labeling available to 
the public through the Internet and would also provide search tools to 
facilitate locating information concerning a particular home-use device 
or a particular type of home-use device.

DATES: Submit either electronic or written comments on the proposed 
rule by January 17, 2017. In accordance with 21 CFR 10.40(c), in 
finalizing this rulemaking FDA will review and consider all comments 
submitted before the time for comment on this proposed regulation has 
expired.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by November 16, 2016; see section VI, 
the ``Information Collection Requirements'' section of this document. 
See section VIII of this document for the proposed effective date of a 
final rule based on this proposed rule.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2491 for ``Electronic Submission of Labeling for Certain 
Home-Use Medical Devices.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your

[[Page 71416]]

comments only as a written/paper submission. You should submit two 
copies total. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
comments. The second copy, which will have the claimed confidential 
information redacted/blacked out, will be available for public viewing 
and posted on http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. If you do not wish your name and 
contact information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of 
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
oira_submission@omb.eop.gov. All comments should be identified with the 
title, ``Medical Devices: Submission of Home-Use Device Labels and 
Package Inserts to FDA''.

FOR FURTHER INFORMATION CONTACT: Antoinette (Tosia) Hazlett, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993, 301-
796-6119, email: Tosia.Hazlett@fda.hhs.gov.
    With regard to the information collection: FDA PRA Staff, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Public Health Benefits
    C. Overview of the Proposed Rule
    D. Public Participation in Setting the Scope and Objectives of 
the Proposed Rule
III. Description of the Proposed Rule
    A. Scope of the Proposed Rule
    1. What devices would be subject to the proposed rule?
    2. When would a home-use device label and package insert be 
submitted to FDA?
    3. Would every type of package insert regarding a home-use 
device have to be submitted to FDA?
    4. Would the rule provide for the submission of advertisements 
or of labeling other than device labels and package inserts?
    5. Would the rule require any change to an existing label or an 
existing package insert?
    B. Submission of Device Labels and Package Inserts to FDA for 
Certain Home-Use Devices
    1. Who would be required to submit labels and package inserts to 
FDA when listing a home-use device?
    2. How would labels and package inserts be submitted to FDA?
    3. What would be the consequences of failing to submit the 
listing information identified in this proposed rule?
    C. Dissemination of the Information Collected Under the Rule
    1. How does FDA intend to make available the information 
collected under the rule?
    2. How will members of the public be able to find information 
collected under this rule and related FDA information concerning a 
home-use device?
    D. Proposed Amendments to Part 807
    1. New Defined Terms
    2. Conforming Amendment of Sec.  807.26(e)
    3. Proposed Requirement To Submit the Label and Package Insert 
of Certain Home-Use Devices
    E. Effective Date
IV. Legal Authority
V. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
    C. Summary of Regulatory Flexibility Analysis
VI. Information Collection Requirements
VII. Analysis of Environmental Impact
VIII. Proposed Effective Date
IX. Federalism
X. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to require certain medical device establishments 
listing devices under section 510(j) of the FD&C Act (21 U.S.C. 
360(j)), if the device is labeled for home use, to submit the device 
label and package insert of such listed medical device, in the 
electronic format mandated in the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), when the device is 
listed with FDA. (See section 510(p) of the FD&C Act.) FDA plans to 
make this device labeling information available to the public through 
an FDA-managed or partner Internet Web site.

B. Summary of the Major Provisions of the Proposed Rule

    The electronic submission requirements of the proposed rule would 
be limited to only devices labeled for home use that are regulated by 
the Center for Devices and Radiological Health (CDRH) as class II and 
class III devices. For purposes of the proposed rule, a ``home-use 
device'' is any medical device that is labeled for use outside a 
professional health care facility. Sampling information indicates that 
this device group has a higher risk of misuse due to lost or misplaced 
labeling and operating instructions. In addition, the proposed rule 
would allow the voluntary electronic submission of device labels and 
package inserts for any class I home-use device or other home-use 
device not subject to the electronic submission requirements of the 
rule.

C. Legal Authority

    FDA is issuing the provisions of this proposed rule that would 
implement the listing requirement for the submission of labels and 
package inserts for home-use medical devices under section 510(j) and 
section 701(a) (21 U.S.C. 371(a)) of the FD&C Act, which provides FDA 
the authority to issue regulations for the efficient enforcement of the 
FD&C Act. Section 510(p) of the FD&C Act requires that registrations 
and listings under section 510 be submitted to the Secretary by 
electronic means unless the Secretary grants a request for waiver 
because the use of electronic means is not reasonable for the person 
requesting such waiver.

D. Costs and Benefits

    FDA will use the existing FDA's Unified Registration and Listing 
System (FURLS) database and software systems to receive the submitted 
electronic labeling information and will bear the incremental cost of 
launching and maintaining the FDA-managed or partner Web site to 
display and make the submitted information available for the public to 
search and retrieve. The

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benefits of this proposed rule would stem from a reduced incidence of 
adverse events due to the increased availability of medical device 
labeling. We estimate that the present discounted value number of 
people most likely to benefit from this rule over 10 years is 66.9 
million, using a 7 percent discount rate, or 80.1 million, using a 3 
percent discount rate. We estimate that the present discounted value of 
costs over 10 years would range from $48.5 to $51.7 million at a 7 
percent discount rate and from $52.5 to $56.5 million at a 3 percent 
discount rate.

II. Background

A. Introduction

    The Medical Device Amendments of 1976 amended section 510(j) of the 
FD&C Act to add requirements for registration of device establishments 
and listing of medical devices. Section 510(j) requires that every 
person who registers shall list all devices manufactured, prepared, 
propagated, compounded, or processed by him for commercial 
distribution. The statute provides that, for all devices subject to the 
listing requirement, the list must be accompanied by copies of the 
device label and, as defined in this proposed rule, the package insert. 
(See section 510(j)(1)(B)(ii) of the FD&C Act.) Our definition of 
``package insert'' in this proposed rule would apply only to proposed 
subpart F. The statute also provides additional listing requirements 
for the submission of labeling and advertising for certain categories 
of devices (see section 510(j)(1)(A) and 510(j)(1)(B)(i) of the FD&C 
Act), which are not relevant to this proposed rulemaking.
    When section 510(j) was added to the FD&C Act in 1976, and for many 
years thereafter, medical device registration and listing required the 
submission of paper forms to FDA. The forms had to be manually 
transcribed by FDA into its data systems, and the data stored primarily 
on reels of magnetic tape and floppy disks. There was no practical way 
for FDA to compile, update, or access the information submitted on 
these forms, much less provide routine public access to the 
information.
    Taking these factors into consideration, when FDA proposed 
regulations regarding the device listing requirements, we explained 
that, instead of requiring the submission of ``information that FDA may 
not have immediate need for, and unless constantly updated by the owner 
or operator, would be out of date when needed,'' FDA by regulation 
would require that the owner or operator maintain a historical file of 
labels, labeling, and for restricted devices, advertisements, and make 
all or part of that file available to FDA upon request. (See 42 FR 
52808 at 52809 (September 30, 1977).) That approach has remained in 
place since the final rule was issued in 1978 (43 FR 37990 (August 25, 
1978)). The regulation made clear that FDA could require the submission 
of device labeling upon request by letter. Id.
    In 2002, Congress recognized the technological and practical impact 
of the Internet when it passed the Medical Device User Fee and 
Modernization Act (MDUFMA) (Pub. L. 107-250). Section 206 of MDUFMA 
amended section 502(f) of the FD&C Act (21 U.S.C. 352(f)) to authorize 
electronic labeling for a device intended for use in health care 
facilities, provided the manufacturer afforded health care facilities 
the opportunity to request the labeling in paper form without 
additional cost. Section 207 of MDUFMA added section 510(p) to the FD&C 
Act, giving FDA the authority to collect registrations and listings 
``by electronic means'' at such time as FDA determined it was feasible 
to receive such information through electronic means. In doing so, 
Congress observed the following:

    The Internet and increased computer usage have created a 
preference in many users for information for use applicable to 
prescription devices in electronic form. Even casual users of 
computers have become used to receiving electronic information . . . 
. The [legislation] conforms FDA practice to the norm by allowing 
manufacturers to provide healthcare facilities (such as hospitals, 
doctors' offices and clinics) labeling in this alternative medium . 
. . . This will better allow manufacturers to provide such 
facilities with information that is more robust, up-to-date, and 
user-friendly. . . Given the increased reliance on computer usage, 
[MDUFMA section 207] requires manufacturers to provide registration 
information required under section 510 by electronic means . . . 
upon a finding by [FDA] . . . that electronic receipt of such 
information is feasible. . . .\1\

    \1\ H.R. Report. No. 107-728, at 41, 107th Cong., 2d Sess. 
(2002) (explaining MDUFMA sections 206 and 207).
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    Subsequently, section 224 of FDAAA struck the language that 
required FDA to make a finding that receipt of electronic submissions 
``is feasible'' and instead made the submission of registration and 
listing information by electronic means mandatory in all instances, 
except where FDA grants a request for waiver of the requirement for a 
person for whom electronic submission ``is not reasonable.'' (See 
section 510(p) of the FD&C Act.)
    This preamble explains how FDA is proposing to further implement 
sections 510(j) and 510(p) of the FD&C Act, by amending FDA's listing 
regulations to require the submission of electronic versions of the 
label and package insert for certain home-use medical devices when 
these devices are listed with FDA. For purposes of this proposed rule, 
the term ``home-use device'' would mean a medical device labeled for 
use in any environment outside a professional health care facility.
    A ``professional health care facility'' is either (1) any 
environment where personnel with medical training are continually 
available to oversee or administer the use of medical devices, 
including, but not limited to, hospitals, long-term care facilities, 
nursing homes, emergency medical services, clinics, physicians' 
offices, and outpatient treatment facilities; or (2) a clinical 
laboratory. A ``clinical laboratory'' is a facility that (1) performs 
testing on materials derived from the human body for the purpose of 
providing information for the diagnosis, prevention, or treatment of 
any disease or impairment of, or assessment of the health of, human 
beings; and (2) has been certified to perform such testing under the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. 
263a) in accordance with 42 CFR part 493, or is CLIA-exempt. These 
definitions of ``professional health care facility'' and ``clinical 
laboratory'' are only meant to provide guidance as to the application 
of proposed subpart F and are not meant for any other purpose, 
including the application of 42 U.S.C. 263a and 42 CFR part 493.
    FDA is proposing that the home-use devices that would be subject to 
this proposed rule, if finalized, are those that are regulated by CDRH 
as class II or class III devices. This proposed rule would not apply to 
any class I devices, nor would it apply to devices regulated by the 
Center for Biologics Evaluation and Research (CBER), except to allow 
the voluntary submission of a device's label and package insert for 
such home-use devices under proposed Sec.  807.220(a) (21 CFR 
807.220(a)).
    This proposed rule is intended to focus on higher-risk home-use 
devices. Under the FDA device classification system, the Agency 
classifies a device into a particular class based on the level of 
control necessary to provide a reasonable assurance of its safety and 
effectiveness, with class I requiring the least amount of control and 
class III requiring the most. (See sections 513(a)(1)(B) and 
513(a)(1)(C)(i)(I) of the FD&C Act (21 U.S.C. 360c(a)(1)(B) and 360c 
(a)(1)(C)(i)(I)).) The proposed rule

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focuses on class II and class III devices, which are considered 
moderate- to high-risk devices, and, except for permitted voluntary 
submissions, does not implicate class I home-use devices. By limiting 
implementation to these home-use devices, the proposed rule would focus 
on those types of home-use devices where patients, caregivers, and 
health care professionals have a significant need for quick and easy 
access to information to help ensure a device can be used safely to 
achieve its intended health benefits. Further, limiting the scope of 
the proposed rule to a small subset of important home-use devices will 
allow FDA to gain experience with the receipt, archiving, and 
dissemination to the public of electronic versions of device labels and 
package inserts before we consider any broader implementation, which 
should create efficiencies with regard to Agency resources.

B. Public Health Benefits

    Home-use devices have significant public health importance to 
patients, caregivers, and health care professionals. But when used in 
an environment where a health care professional is not available to 
provide supervision and assistance, the Agency recognizes that these 
devices can present unique concerns and challenges (Ref. 1). In this 
preamble, we use the term ``patient'' to refer to any health care 
recipient, including someone who is not receiving care from a health 
care professional, e.g., a person with a chronic condition who self-
administers a treatment, or a person who receives care from a family 
member or friend. We use the term ``caregiver'' to refer to a person 
who provides voluntary help or care, e.g., a family member, friend, 
neighbor, or acquaintance, and we use ``health care professional'' to 
refer to someone whose profession is in the health care sector, e.g., a 
physician or a visiting nurse who provides care in the course of his or 
her duties. Because our use of these terms corresponds to their 
ordinary (plain language) meanings, we are not proposing regulatory 
definitions. In discussing patient labeling considerations for medical 
devices in general, we used similar terminology in ``Guidance on 
Medical Device Patient Labeling: Final Guidance for Industry and FDA 
Reviewers'' (Ref. 2).
    Medical devices are different from other FDA-regulated medical 
products--e.g., drugs and biologics--in that many devices are commonly 
intended to be used for many years and often do not have explicit 
expiration or recommended ``use-by'' dates. When a home-use device is 
used over a period of years, it becomes increasingly more likely that 
it may be separated from its original labeling or that its original 
labeling will not include current safety information or instructions 
for use. Additionally, home-use devices are much more likely to be used 
by lay users, who frequently have not been trained to use such medical 
devices and who are especially reliant on the instructions for use and 
other information provided by the device label and package insert. In 
contrast with use in professional health care settings, a patient or 
caregiver using a home-use device in a setting without professional 
oversight may not have extensive experience in the use of a device and 
may not have ready access to the original packaging or to alternative 
sources of information about a device.
    Those people that use home-use devices are particularly vulnerable 
to adverse events because they may be inexperienced in the proper use 
and maintenance of the devices. In 2014, there were over 800,000 
adverse events associated with medical devices. Our review of adverse 
reports that meet the criteria for faster level of review (Code Blue 
reports of deaths, fires, explosions, etc.) found, on average, three to 
five such reported events per week as having occurred in the home 
environment, i.e., outside of a clinical facility. The Agency believes 
that device labeling information that would be submitted under this 
proposed rule and made readily accessible on an FDA-managed or partner 
Web site could reduce the incidence of adverse events when the labeling 
is lost or misplaced and the user is inexperienced with the home-use 
device, or when the labeling of the device has been updated with new 
information.
    When a home-use device becomes separated from its labeling--and the 
user no longer has ready access to the important information provided 
in those materials, such as indications for use, contraindications, 
warnings, precautions, and instructions for setup, use, and maintenance 
of the device--the device user may be faced with serious obstacles to 
the safe and effective use of the device (Ref. 3). The absence of such 
critical information may lead to the device being used incorrectly, 
which could result in the delay of proper treatment or even injury to 
the patient. Improper use of a device can expose both the patient and 
caregiver to potentially serious risks--risks that could be avoided if 
information presented in the device's labeling was readily available. 
In addition, health care professionals, including emergency personnel 
who need to gain a rapid understanding of the operation and limitations 
of a device, may be left unsure as to how to best respond to a critical 
situation.
    When the labeling that describes how to operate a device is 
missing, there is a higher chance that a device might be misused. CDRH 
has received reports of unavailable labeling for devices that could be 
dangerous when used by patients or caregivers outside a professional 
health care facility. For example, missing labeling for something as 
simple as a patient lift is dangerous when an elderly caregiver needs 
to understand how to assemble and safely operate the lift. Another 
example is a patient on home hemodialysis who needs to refer to 
available labeling for proper warnings and precautions, water type, or 
filters needed.
    Although many manufacturers have Internet sites that provide 
information concerning the devices they currently market, those sites 
typically focus on newer products and often do not provide any 
information on devices that they no longer actively market. Sites also 
vary considerably in the types of information provided and may lack 
important details concerning their devices. Although some 
manufacturers' Web sites provide some labeling, FDA believes that most 
do not provide the label and package insert for all of their home-use 
devices listed with FDA.
    The proposed rule would help to address these concerns by making it 
possible for FDA to establish an electronic database, published online 
and accessible to the public through the Internet, of labels and 
package inserts for listed home-use devices that would be submitted 
under this proposed rule. This database would fill an important gap in 
the information available to patients, caregivers, and the health care 
community concerning these home-use devices, and would allow both broad 
searches to identify legally marketed home-use devices that may fill a 
particular need and focused searches to obtain information concerning 
the use of a specific home-use device. In recent years, patients have 
become more involved in decisions concerning their health care, 
including the types of treatments they will undergo, the selection of 
specific home-use devices to be used in their treatment, and 
administration of the course of treatment (Ref. 4). This trend shows no 
signs of abating. With less day-to-day oversight by health care 
professionals, consumers have assumed responsibilities that have been 
traditionally borne by health care professionals. For example, 
consumers

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may take on responsibility for setting up a home-use device, monitoring 
its performance, performing basic maintenance, and more. Because of 
this expanding role, consumers need to understand the risks and 
benefits of particular home-use devices in order to make informed 
decisions concerning their treatment options, and need ready access to 
information that will help them use devices properly, as intended by 
the manufacturers.
    The FDA-managed or partner Internet Web site would provide a 
consolidated and easily accessible source of FDA database information 
concerning class II and class III home-use devices, including their 
approval or clearance status, intended uses, limitations, setup, and 
operation. The FDA database would not contain identifiable private 
information nor provide access to ``lock out'' information that is not 
included on the device labeling but is furnished through a source 
referenced in the device labeling, e.g., information contained on a 
manufacturer's Web site, access to which is limited to professionals or 
some other restricted class of users. The FDA-managed or partner 
Internet site would contain links to other FDA information concerning 
the device, such as premarket submission information (e.g., the summary 
of safety and effectiveness for a device), adverse event reports, 
alerts and notices, and recalls, as well as FDA information concerning 
the manufacturer. The information provided by FDA would help ensure 
greater safety and effectiveness of class II and class III home-use 
devices, particularly when a device has become separated from its 
labeling or when health care professionals, including visiting home 
nurses and emergency rescue personnel with varied skills and 
experience, need rapid access to information about unfamiliar products 
to help resolve a medical emergency. FDA would be able to make such 
information available from the time the device is first listed and, 
because the use of a device can continue long after a manufacturer 
ceases to market the specific device, we would continue to provide 
information even after the device is no longer marketed and no longer 
listed. FDA expects to provide search tools to facilitate locating 
information concerning a particular device or a particular type of 
device.
    FDA also intends to make available the information collected under 
this rule through other partner Web sites that provide medical and 
health information to the public. For example, ``Daily Med'' (http://dailymed.nlm.nih.gov) is an Internet site administered by the National 
Institutes of Health's National Library of Medicine (NLM) that provides 
access to the labels and package inserts of prescription drugs. FDA 
believes that the public access to the labels and package inserts of 
the home-use medical devices covered by this proposed rule would 
provide a benefit similar to that provided by Daily Med in the drugs 
context.

C. Overview of the Proposed Rule

    The proposed rule, if finalized, would implement provisions of 
sections 510(j)(1)(B)(ii) and 510(p) of the FD&C Act by amending FDA's 
listing regulations to provide that the label and package insert must 
be submitted electronically to FURLS, as part of the information 
required to list any home-use device regulated by CDRH as a class II or 
class III device. Section 510(j) requires manufacturers to list their 
medical devices and outlines the types of information that must 
accompany each listing. However, this proposed rule would apply only to 
class II and class III home-use devices regulated by CDRH, which 
represents a subset of devices that are subject to section 510(j) of 
the FD&C Act. For class II and class III home-use devices, the rule 
would amend the device listing regulations to provide that 
establishments listing such devices must submit to FDA a copy of the 
label and package insert of such home-use devices, when they are listed 
with FDA by electronic means, in an electronic format that we will 
specify and not as printed (paper) copies.
    Unless a request for waiver is granted, all of the information 
submitted to FDA under the proposed rule would have to be submitted by 
electronic means, as required by section 510(p) of the FD&C Act, in a 
format to be specified by FDA that we can process, review, and archive. 
Initially, we intend to allow for the submission of labels and package 
inserts saved in Portable Document Format (PDF). The PDF format is a 
broadly used format that preserves both the content and appearance of a 
source document (such as a device label or package insert) and which 
can be read on all mainstream personal computers, regardless of the 
operating system, using freely available software. In addition, a wide 
variety of software packages and operating systems allow a source 
document to be saved as a PDF file. FDA believes that all listing 
establishments are already familiar with the PDF format, and that most 
already have the ability to save source documents as PDF files. We 
intend to make available additional information that will provide 
details and recommendations regarding this process by the time we 
publish a final rule.
    At a later time, we expect to provide processes for the submission 
of labels and package inserts based on FDA's Structured Product 
Labeling (SPL) document standard. This would make it easier for FDA and 
the public to store, retrieve, and search information in home-use 
device labels and package inserts. We are considering at least two such 
processes--one process that would make it easy for a small business 
with limited means to submit SPL information by manually entering or 
uploading the information for one product at a time on an FDA Web page 
(this type of process is often referred to as a ``data entry'' 
process), and a second process that would provide an efficient way to 
submit SPL data for multiple devices in a single submission (this type 
of submission process is often referred to as a ``batch submission'' 
process). We intend to provide information explaining each process as 
it becomes available.
    FDA plans to retain all labels and package inserts submitted under 
this rule in FDA's FURLS database. Not all information in the FURLS 
database is available to the public, so we intend to make the submitted 
labeling accessible to the public through an FDA-managed or partner 
Internet Web site, such as NLM, even after a device is no longer 
listed. However, if FDA bans a device under section 516 of the FD&C Act 
(21 U.S.C. 360f), we intend to remove any label and package insert from 
our FURLS database and from any other FDA or partner Web site we might 
use and replace those materials with a statement explaining that the 
device has been banned. If a device is recalled, we may add a notice to 
the labeling database, with additional information to help ensure the 
safe and effective use of the device, or advice to discontinue use of 
the device and additional steps to take to help ensure the health and 
safety of the patient or user of the device.

D. Public Participation in Setting the Scope and Objectives of the 
Proposed Rule

    FDA used comments from the medical device industry, health care 
professionals, caregivers, and patients to help formulate the 
objectives and define the scope of this proposed rule. In September 
2009, CDRH established the ``510(k) Working Group'' and the ``Task 
Force on the Utilization of Science in Regulatory Decision Making'' to 
address concerns about how well the 510(k) program (the primary 
regulatory route to market for medical devices) was meeting its public 
health goals of

[[Page 71420]]

facilitating innovation and assuring the safety and effectiveness of 
medical devices. As part of these reviews, FDA held two public meetings 
and three town hall meetings, solicited comments through three open 
public dockets, and met with many stakeholders over several months. In 
August 2010, CDRH released for public comment preliminary reports from 
these committees. The preliminary reports expressed concern regarding 
the lack of ready access to final device labeling and recommended:
     FDA should ``take steps to improve medical device 
labeling, and to develop an online labeling repository to allow the 
public to easily access this information.'' (Ref. 5)
     FDA should ``revise existing regulations to clarify the 
statutory listing requirements for the submission of labeling.'' (Ref. 
6)
     FDA should ``explore the feasibility of requiring 
manufacturers to electronically submit final device labeling to FDA . . 
. and also to provide regular, periodic updates to device labeling, 
potentially as part of annual registration and listing or through 
another structured electronic collection mechanism.'' (Ref. 6)
    The preliminary reports also recommended that if FDA requires 
submission of device labels, they be ``posted as promptly as feasible 
on the Center's public 510(k) database.'' (Ref. 6)
    FDA received comments on these recommendations from industry, 
consumer, and health care professional groups. Some industry 
representatives expressed concern regarding the potential for 
disclosure of confidential or proprietary information. According to 
some industry representatives, device-specific information on device 
labels is not necessarily appropriate for the general public, but 
rather is intended for physicians or other health care professionals 
and may cause confusion if they are made available in a public 
database. Furthermore, industry suggested that the responsibility for 
disseminating labeling should rest solely with the manufacturer and 
should remain in the manufacturer's control. Industry also stated that 
many updates to labeling are made for marketing purposes and not 
related to regulatory requirements or device alterations.
    Consumer and health care professional groups supported the 
recommendation of the 2010 510(k) Working Group and the Task Force 
preliminary reports. Their comments noted that providing access to 
online labeling resources would facilitate better-informed clinical 
decisionmaking.
    In January 2011, FDA issued a ``Plan of Action'' outlining steps we 
will take to improve the 510(k) program and explaining our views and 
responses to comments we received concerning recommendations made in 
the August 2010 preliminary reports (Ref. 7). FDA agreed with comments 
that making labeling readily available could lead to better-informed 
clinical decisionmaking. Just as the FDA's central database for drug 
labeling conveys a public health benefit, we believe that a similar 
database for devices would be of significant benefit to the public 
health by providing useful information to health care professionals and 
patients. Although submission of labels and certain other labeling for 
all devices is a statutory requirement, FDA determined that it was 
important to seek additional stakeholder input at a public meeting 
before proposing any regulatory changes.
    FDA held another public meeting in April 2011, specifically to 
discuss options, benefits, costs, and concerns regarding the collection 
of device labels and certain labeling and means of making the resulting 
information available to the public, including industry, health care 
professionals, caregivers, and patients (Ref. 8). Industry 
representatives did not support a system that would require submission 
of labels and other labeling for all devices to FDA, but generally 
agreed that there would be value in a more limited system, particularly 
with regard to devices intended for home use. Health care professionals 
and caregiver representatives were supportive of a broad system, but 
willing to consider any approach that would increase their access to 
reliable device information.
    Reports by FDA's committees recommended that FDA fully implement 
section 510(j) by developing an electronic submission method for labels 
and package inserts for devices generally and many stakeholders 
supported the creation of a broad ``repository'' (essentially, an FDA-
managed database accessible to the public through an Internet site) of 
labeling for all devices. However, FDA believes, at this stage, that 
the public health need for, and the opportunity to improve access to 
home-use device information call initially for the more-limited actions 
pursued in this proposed rule. In order to minimize risks and costs 
while we gain experience with implementing and managing electronic 
labeling, the Agency is limiting this proposed rule to only include the 
submission of labels and package inserts from home-use devices 
regulated by CDRH as class II or class III devices. As FDA and the 
public gain experience with the electronic submission of labeling and 
use of the planned searchable FDA-managed or partner Internet Web site, 
FDA will consider whether to implement this requirement for other 
categories of devices, or for devices generally.
    FDA also conducted a series of followup focus group interviews of 
health care professionals to obtain their individual views concerning a 
wide variety of topics relating to medical device labeling, resulting 
in a series of reports, including ``Medical Device Labeling for Health 
Care Practitioners: Focus Group Study'' (May 2011) (Ref. 9) and 
``Device Labeling Study: Practitioner Perspectives on Utility, Format, 
and Content of an Abbreviated Version of Labeling'' (March 2013) (Ref. 
10). Participants saw considerable value in having device labeling 
available online for quick access when needed; participants noted that 
labeling that is not directly placed on a device--for example, a 
manual--can be hard to find when needed. Unlike a device label or 
package insert, information made available through the Internet is 
always readily available and cannot be lost or misplaced. Most 
participants favored having access to labeling through an Internet Web 
site, particularly if well-organized.
    Additionally, in September 2015, FDA held a public meeting to 
discuss issues associated with medical device patient labeling that 
involved development, use, and access to device information (Ref. 11). 
At this meeting, many external stakeholders stated their belief that 
providing labeling in one place for consumers that is reliable and 
dynamic would increase accessibility to labeling for legacy devices and 
to labeling updates as new information becomes available for currently 
marketed devices. Also, while device information from other sources 
such as Web sites and YouTube videos may be useful, stakeholders 
indicated concern that some may be potentially erroneous and contain 
mostly promotional information.

III. Description of the Proposed Rule

A. Scope of the Proposed Rule

1. What devices would be subject to the proposed rule?
    A device would be subject to the proposed rule if it is a ``home-
use device'' as defined by proposed Sec.  807.200, that is regulated by 
CDRH as a class II or class III medical device. Under this proposed 
regulation, a

[[Page 71421]]

``home-use device'' would be any medical device that is labeled for use 
outside a professional health care facility. Home-use devices that are 
co-labeled for, or can be used in a professional health care facility, 
would be subject to this proposed rule if the device is labeled for use 
in a patient's home or in any other environment that is not a 
professional health care facility.
    Class I devices and devices regulated by CBER are not within the 
scope of the proposed rule, except for the authorized voluntary 
submission of a device's label and package insert for these home-use 
devices (under proposed Sec.  807.220(a)). For more information about 
the definition of ``home-use device,'' please refer to section III.D.1 
of this document.
2. When would a home-use device label and package insert have to be 
submitted to FDA?
    Proposed Sec.  807.205 would require the label and package insert 
of a home-use device subject to the proposed rule to be submitted 
whenever any provision within part 807 (21 CFR part 807) requires 
listing information to be submitted or updated. For example, the label 
and package insert would be required with such home-use device's 
initial listing required by Sec.  807.22(a), with each annual listing 
under Sec.  807.22(b), and whenever an action triggers a reporting 
requirement under Sec.  807.28. If the label and package insert have 
already been submitted and have not been changed since they were last 
submitted to FDA, the establishment may simply certify that no change 
has been made to the previously submitted labeling; see proposed Sec.  
807.300(a). An updated label or package insert could be submitted 
voluntarily at any time; see proposed Sec.  807.300(b).
3. Would every type of package insert regarding a home-use device have 
to be submitted to FDA?
    No. The rule would limit the definition of ``package insert'' to 
include only those informational materials directed to the intended 
user of the device, and which are provided in a device package or which 
accompany the device when it is delivered to the user, including when 
already provided by electronic means. (See the proposed definition of 
package insert at Sec.  807.200.) Only package inserts meeting this 
definition would have to be submitted to FDA. We have chosen to limit 
the scope of package insert in order to focus the proposed rule on 
those package inserts that are essential to typical intended uses and 
typical users of the home-use devices subject to this proposed rule. 
Examples of materials that would not be within the scope of the 
proposed rule include materials that are not intended for a patient 
(care recipient) or for the caregiver, health care professional, or 
family member who directly operates or handles the device or provides 
assistance to the patient in using the device, e.g., an installation 
and calibration manual intended for technical or support personnel; 
supplemental training materials; supplemental service manuals; 
supplemental materials that concern optional additional uses that 
require accessories not included with the listed home-use device; and 
any supplemental materials that are made available only upon request or 
only upon payment of a separate fee.
4. Would the rule provide for the submission of advertisements or of 
labeling other than device labels and package inserts?
    No. The proposed rule would not address the submission of 
advertisements or of labeling other than the device label and package 
insert.
5. Would the rule require any change to an existing label or package 
insert?
    No. The proposed rule would not affect the form or content of home-
use device labeling. Existing labeling requirements would continue to 
apply, including those of part 801 (Labeling) and Sec.  809.10 
(Labeling for in vitro diagnostic products.).

B. Submission of Device Labels and Package Inserts to FDA for Certain 
Home-Use Devices

1. Who would be required to submit labels and package inserts to FDA 
when listing a home-use device?
    The owner or operator of an establishment (the remainder of this 
preamble will simply refer to ``the establishment'') that lists a class 
II or class III home-use device subject to this proposed rule would be 
responsible for submission of the label and package insert, just as the 
establishment is responsible for submitting all other listing 
information pertaining to the device. (See proposed Sec.  807.205.)
2. How would labels and package inserts have to be submitted to FDA?
    The proposed rule provides for the electronic submission of this 
information to FDA, as required by section 510(p) of the FD&C Act, in a 
form specified by FDA that we can process, review, and archive; see 
proposed Sec.  807.205. Initially, FDA expects to specify saving the 
device label and package insert as PDF files and submitting those 
materials to FDA. Later, we expect to transition from submission of 
PDFs to submission of SPL-formatted information. We intend to publish 
information describing the entire proposed process by the time we 
publish a final rule. If a waiver from filing registration and listing 
information electronically has been obtained under Sec.  807.21(b), the 
establishment would be required to submit the device labels and package 
insert called for in this proposed rule in the same manner as permitted 
for other registration and listing information covered by the waiver, 
as directed by Sec.  807.34.
    When the proposed rule is finalized, an establishment submitting a 
home-use device's label and package insert would confirm or provide the 
FDA-assigned premarket submission number of the device (Sec.  
807.25(g)(4)) or the product codes for 510(k)-exempt devices (Sec.  
807.25(g)(2)).
3. What would the consequences be of failing to submit the listing 
information identified in this proposed rule?
    The failure to provide information required by section 510(j) of 
the FD&C Act, as implemented by part 807, including proposed subpart F, 
causes a device to be misbranded under section 502(o) of the FD&C Act 
and is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 
331(p)), which may result in seizure, injunction, or other penalties.

C. Dissemination of the Information Collected Under the Rule

1. How does FDA intend to make available the information collected 
under this rule?
    FDA intends to make the labels and package inserts collected under 
this rule available on an FDA-managed or partner Internet Web site. We 
intend to link the labels and package inserts submitted under this rule 
to the listing record for the particular device. Over time, and as 
resources permit, we also intend to link each device listing to other 
FDA information, such as the device identifier required by FDA's unique 
device identification system, FDA premarket submission numbers, adverse 
event reports, and public health notifications, so that users of the 
planned FDA-managed or partner Internet Web site will also be able to 
access public information that is maintained in FDA's other databases 
concerning devices marketed or manufactured in the United States.

[[Page 71422]]

2. How will members of the public be able to find information collected 
under this rule and related FDA information concerning a home-use 
device?
    We intend to provide several ways to search for information, such 
as the ability to search by:
     Proprietary name (for a specific device);
     Product code (for a generic type of device);
     Firm name (for all devices listed by a particular firm);
     FDA premarket submission number;
     Device identifier (the static portion of the unique device 
identifier required by Sec. Sec.  801.20 and 801.40).
    We also intend to provide a means to search the full text of labels 
and package inserts using free-form searches.

D. Proposed Amendments to Part 807

1. New Defined Terms
    FDA is proposing to add definitions for two terms to part 807; 
these terms have not been defined in any prior medical device 
regulation: Home-use device and package insert.
    Home-use device would mean a medical device that is labeled for use 
in any environment outside a professional health care facility. This 
definition is meant to make clear that ``home-use device,'' as defined 
in this proposed rule, would not be restricted in a literal sense to 
use in a patient's home, but is instead meant to take in a broader 
range of environments in which a device may be used outside of a 
professional health care facility.
    If finalized, the definition of home-use device is meant to apply 
only to proposed subpart F for purposes of submitting the device's 
label and package insert when listing under section 510(j) of the FD&C 
Act. This proposed regulation would not apply for other purposes, 
including premarket submission determinations. Additionally, proposed 
Sec.  807.200 would not apply for purposes of CLIA categorization under 
42 CFR 493.15. The fact that a device would be considered a ``home-use 
device'' under this proposed regulation would not mean that the device 
has been ``cleared by FDA for home use'' within the context of 42 CFR 
493.15, a regulatory provision related to the implementation of the 
CLIA provisions found at 42 U.S.C. 263a.
    Package insert would mean all informational materials directed to 
the user of the device, and which are provided in a device package or 
which contemporaneously accompany the device when it is delivered to 
the user, including by electronic means. Although the term is used in 
section 510(j)(1)(b)(ii) of the FD&C Act (see the discussion of section 
510(j) in section I. Background) and in various medical device 
regulations, this term is not defined in the FD&C Act or by any medical 
device regulation. A package insert is one type of device labeling. Our 
definition of ``package insert'' in this proposed rule would also apply 
only to proposed subpart F.
2. Conforming Proposed Amendment of Sec.  807.26(e)
    We would amend the first sentence of Sec.  807.26(e) to strike the 
word ``only.'' This change is necessary to avoid conflict between the 
proposed regulatory amendments pertaining to the submission of labels 
and package inserts of home-use devices under new subpart F of this 
proposed rule and Sec.  807.26(e), which states that owners or 
operators shall be prepared to submit such information ``only upon 
specific request'' (emphasis added). The submission of labeling for 
home-use devices that new subpart F of this proposed rule would require 
would not be responding to a targeted ``specific request'' for 
information under existing Sec.  807.26(e). The proposed requirements 
to submit such information under new subpart F would conflict with 
Sec.  807.26(e), as currently worded, but would not conflict with 
proposed Sec.  807.26(e), as amended. FDA does not intend this change 
to result in a greater number of requests for information under Sec.  
807.26(e), and we do not intend to request the resubmission of 
information under Sec.  807.26(e) that has already been submitted for 
home-use devices under new subpart F. Related Sec.  807.26(f) 
prohibiting the submission of information requested under Sec.  
807.26(e) from ``using the FDA electronic device registration and 
listing system'' likewise would not apply to the information that would 
be submitted under proposed new subpart F if finalized, which provides 
instead for such information to be submitted ``in a format specified by 
FDA that we can process, review, and archive'' (proposed Sec.  
807.205).
3. Proposed Requirement To Submit the Label and Package Insert for 
Certain Home-Use Devices
    We are proposing a new subpart to part 807, ``Subpart F--Submission 
of Labeling When Listing Certain Home-Use Devices.'' For establishments 
listing home-use devices subject to this proposed rule, proposed Sec.  
807.205 would require that the device label and package insert be 
submitted to FDA whenever any provision within part 807 requires 
submission of listing information regarding the device.
    Proposed Sec.  807.220 would make clear that the voluntary 
submission of the label and package insert of a home-use device that is 
not required under this proposed rule would be permitted. Proposed 
Sec.  807.220(a) would make clear that for such devices, including a 
home-use device regulated by CBER, the owner or operator subject to 
part 807 could voluntarily submit the device label and package insert, 
which FDA could then make available to the public.
    Proposed Sec.  807.220(c) would make clear that the label and 
package insert for a discontinued home-use device could be submitted, 
which FDA could then make available to the public. This provision would 
provide a way for an establishment to make information about a 
discontinued home-use device available to the public, potentially 
reducing the burden of responding to requests for information about a 
discontinued device.
    Proposed Sec.  807.300 would explain when an updated device label 
and package insert must be submitted.
    Proposed Sec.  807.300(a) would reduce the burdens of the proposed 
rule, if finalized, following the initial submission of listing 
information to FDA by making it clear that resubmission of the label 
and package insert of a home-use device each year during the annual 
listing process, and in other circumstances when updated listing 
information must be submitted, would not be required unless changes 
have been made. Instead, if no change has been made to the most-
recently submitted label and package insert, FDA would only require a 
statement to that effect. We expect this statement will be as simple as 
clicking a check-box within one of the processes FDA expects to 
provide.
    Proposed Sec.  807.300(b) would make clear that updated labeling 
information for a home-use device that is not required under this 
proposed rule, such as a CBER-regulated home-use device, could 
voluntarily be submitted at any time. We expect the majority of 
labelers will see advantages to keeping this information up-to-date, as 
a way of better serving current and potential users of their devices.
    We would make a conforming amendment to Sec.  807.40 to apply the 
requirements of proposed subpart F to listings by foreign 
establishments. This would ensure that both domestic and foreign 
establishments will be subject to the same requirements regarding the 
submission of labels and package inserts for home-use devices.

[[Page 71423]]

E. Effective Date

    FDA is proposing that this rule would go into effect 90 days after 
publication of a final rule, if that results in an effective date prior 
to October 1 of the year of publication; otherwise, the rule would go 
into effect on January 1 of the year following publication of a final 
rule. This ensures adequate notice and avoids any possibility that a 
final rule might go into effect part way through an ongoing 
registration and listing cycle (October 1 through December 31 each 
year).
    The proposed rule would implement provisions of the FD&C Act to 
require the submission of class II and class III home-use device labels 
and package inserts with device listing information submitted to FDA on 
or after the effective date of the rule. The rule would not be 
retroactive, and there would be no obligation to submit the label or 
package insert of a discontinued home-use device that was listed at any 
time prior to the effective date of a final rule; but if that device is 
listed during a subsequent registration and listing cycle (a cycle that 
begins after the effective date of a final rule), all listing 
requirements would have to be met, including submission of the label 
and package insert.

IV. Legal Authority

    Section 510(j) of the FD&C Act requires all persons who register 
with the Secretary to file a list of all devices that are being 
manufactured, prepared, propagated, compounded, or processed by them 
for commercial distribution. The listing of all devices is required to 
be accompanied by a copy of the label, package insert, and a 
representative sampling of the labeling for such devices. (See section 
510(j)(1)(B)(ii).) Accordingly, FDA is issuing the provisions of this 
proposed rule that would implement the listing requirement for the 
submission of labels and package inserts for home-use medical devices 
regulated by CDRH under section 510(j) and section 701(a), which 
provides FDA the authority to issue regulations for the efficient 
enforcement of the FD&C Act.
    The provisions of the proposed rule that would require the 
electronic submission of labeling are issued under the authority of 
sections 510(p) and 701(a) of the FD&C Act. Section 510(p) requires 
that registrations and listings under section 510 be submitted to the 
Secretary by electronic means unless the Secretary grants a request for 
waiver because the use of electronic means is not reasonable for the 
person requesting such waiver.
    The failure to include a device in a list required by section 
510(j) causes the device to be misbranded under section 502(o) of the 
FD&C Act. The failure to provide any information required by section 
510(j) is a prohibited act under section 301(p) of the FD&C Act.

V. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. We believe that this 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because annualized costs to small entities are estimated to 
be less than 0.4 percent of firm revenue, we propose to certify that 
the proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $146 million, using the most current (2015) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Costs and Benefits

    This rule proposes to implement provisions of the FD&C Act by 
requiring firms to electronically submit to FDA the device labels and 
package inserts, hereafter in this section of the document referred to 
as ``labeling,'' of certain home-use medical devices. In particular, 
all devices regulated by CDRH as class II and class III devices and 
labeled for use in any environment outside a professional health care 
facility would be covered by this rule. FDA intends to make the 
labeling of these devices available to the public in a searchable FDA-
managed or partner Internet Web site, hereafter referred to in this 
section of the document as ``labeling database.'' Firms would be 
required to submit the device labeling to FDA, initially in PDF format 
but later in SPL format. Firms would incur three types of costs as a 
result of this rule: Costs to read and understand the rule, costs to 
reformat labeling according to the rule, and costs to train personnel 
to comply with the rule. FDA would incur costs to establish and 
maintain the public online labeling database. The public would benefit 
from access to information and instructions on the proper use of 
medical devices in home settings.
    The costs and benefits of the proposed rule are summarized in the 
table 1, entitled ``Economic Data: Costs and Benefits Statement.'' This 
table shows the estimated average annualized costs and other quantified 
but not monetized effects of this rule using both 7 and 3 percent 
annual discount rates over a 10-year evaluation period. We estimate 
that the present value of costs over 10 years would range from $48.5 to 
$51.7 million at a 7 percent discount rate and from $52.5 to $56.5 
million at a 3 percent discount rate. Annualizing these costs over 10 
years yields estimated costs ranging from $6.5 to $6.9 million at a 7 
percent discount rate and $6.0 to $6.4 million with a discount rate of 
3 percent.
    As table 1 shows, the primary benefit stems from a reduced 
incidence of adverse events due to the increased availability of 
medical device labeling. We use, as a proxy for those most likely to 
benefit from this proposed rule, individuals who receive instruction 
from home health providers on the proper and safe use of their home-use 
devices. We estimate that the present value number of home-use device 
training events over 10 years is 66.9 million using a 7 percent 
discount rate or 80.1 million using a 3 percent discount rate. 
Annualized over 10 years, we estimate the annual number of home-use 
device training events is 8.9 million with a 7 percent discount rate 
and 9.1 million with a 3 percent discount rate. Under the proposed 
rule, we estimate that for each home-use device training event, the 
rule would cost between $0.73 and $0.77 using a 7 percent discount 
rate; with a 3 percent discount rate, the cost per event would range 
from $0.66 to $0.71.

[[Page 71424]]



                                                  Table 1--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Units
                                                                                         ---------------------------------------------
            Category              Primary estimate    Low  estimate      High  estimate       Year       Discount                            Notes
                                                                                            dollars      rate (%)    Period  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized $millions/  .................  .................  .................  ...........            7
 year.                                                                                                           3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Quantified..........  8.9 million home-  .................  .................  ...........            7  10 years.........  Reduced incidence
                                  use device                                                                                            of adverse
                                  training events.                                                                                      events due to
                                                                                                                                        availability of
                                                                                                                                        labeling.
                                 9.1 million home-  .................  .................  ...........            3  10 years.........
                                  use device
                                  training events.
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Monetized $millions/  $6.6 million.....  $6.5 million.....  $6.9 million.....         2011            7  10 years.........  Includes industry
 year.                           $6.1 million.....  $6.0 million.....  $6.4 million.....         2011            3  10 years.........   costs to read
                                                                                                                                        and understand
                                                                                                                                        the rule,
                                                                                                                                        reformat
                                                                                                                                        labeling, and
                                                                                                                                        train personnel
                                                                                                                                        as well as FDA
                                                                                                                                        costs to
                                                                                                                                        establish and
                                                                                                                                        maintain the
                                                                                                                                        labeling
                                                                                                                                        database.
Annualized Quantified..........  .................  .................  .................  ...........            7
                                 .................  .................  .................  ...........            3  .................  .................
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Transfers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized     .................  .................  .................  ...........            7  .................  None.
 $millions/year.                                                                                                 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To........................  From:
                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized       .................  .................  .................  ...........            7  .................  .................
 $millions/year.                                                                                                 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To........................  From:
                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects.
--------------------------------------------------------------------------------------------------------------------------------------------------------
State, Local, or Tribal Government.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual cost per affected small entity is estimated to be less than 0.4 percent of revenues.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Wages: No estimated effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Growth: No estimated effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    To determine the impact of the proposed rule on small entities, we 
compare the estimated cost of the rule to the average revenues of the 
small entities. Assuming that each small firm is composed of a single 
establishment, the annualized cost to small entities of the proposed 
rule is not expected to exceed 0.22 percent of firm revenue. The 
largest impact would be felt by firms with fewer than 100 employees. If 
instead we assume that each small firm is composed of three 
establishments, the annualized cost to small entities of the proposed 
rule is not expected to exceed 0.38 percent of firm revenue. Given that 
we estimate the cost of the proposed rule to be a very small percentage 
of firm revenue, the Agency proposes to certify that this proposed rule 
will not have a significant economic impact on a substantial number of 
small entities.
    The full analysis of economic impacts is available in the docket 
for this proposed rule (Ref. 12) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

[[Page 71425]]

VI. Information Collection Requirements

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A 
description of these provisions is given in the Description section of 
this document with an estimate of the annual reporting burden. Included 
in the estimate is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
Medical Devices: Submission of Certain Home-Use Device Labels and 
Package Inserts to FDA
    Description: This proposed rule implements statutory directives of 
section 510(j) of the FD&C Act regarding information required to list a 
medical device, and amendments enacted in 2002 and 2007 with respect to 
section 510(p) of the FD&C Act that require all registration and 
listing information to be submitted ``by electronic means'' (except 
where FDA grants a waiver from the use of electronic means). The 
collection requirements associated with this regulation will help 
ensure that patients, caregivers, and health care professionals have 
free, timely, and unimpeded access to a trusted source of comprehensive 
information essential to the safe and effective use of class II and 
class III home-use devices, even if such devices become separated from 
their original labeling. We believe that the public will benefit from 
the improved availability of information, accompanying search tools, 
and links to other FDA information. Ultimately, it is FDA's hope that 
access to this information will contribute to improved medical outcomes 
and a reduction in adverse events.
    Specifically, if a home-use device is subject to the proposed rule 
its label and any package insert would be required to be submitted 
whenever that device is listed with FDA. Device listing information 
must be submitted electronically to FDA once each year, during the 
period from October 1 through December 31. Once a device's labeling has 
been submitted to FDA, the establishment may thereafter either submit 
revised labeling with each annual listing of the device to which it 
pertains, or may certify that no change has been made to the previously 
submitted labeling. The certification option would simplify the process 
by not requiring the submission of materials that would duplicate 
materials previously submitted to FDA. The proposed rule would make 
clear that the voluntary submission of the label and package insert of 
a home-use device would be permitted in some circumstances. When 
finalized, the information collection requirements outlined in this 
section will amend the current OMB PRA approval for the current 
Registration and Listing Information collection approved under OMB 
control number 0910-0625.
    Description of Respondents: The likely respondents for this 
collection of information are domestic device establishments who plan 
to sell, or who are continuing to sell, their products within the 
United States.
    FDA estimates the burden, on average, of this collection of 
information as follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
Section 510(p)/information collection activity     Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Electronic Labeling Submission........           2,280          5.4114          12,338  0.25 (15 minutes).......................         3,084.5
Ongoing Annual Certification of Labeling                 2,280          1.0825           2,468  0.25 (15 minutes).......................             617
 Submission.
Ongoing Annual Electronic Labeling............           2,280               6          13,680  0.25 (15 minutes).......................           3,420
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         7,121.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title ``Medical Devices: Submission of Home-Use 
Device Labels and Package Inserts to FDA''.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.

VII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Proposed Effective Date

    FDA proposes that this rule will go into effect 90 days after 
publication of a final rule, if that results in an effective date prior 
to October 1 of the year of publication; otherwise, FDA proposes this 
rule will go into effect on January 1 of the year following publication 
of a final rule.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule, if finalized, does not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, we

[[Page 71426]]

conclude that the proposed rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

X. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. ``Medical Device Home Use Initiative,'' FDA, April 2010, 
available at http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf.
2. ``Guidance on Medical Device Patient Labeling; Final Guidance for 
Industry and FDA Reviewers,'' FDA, April 2001, available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070782.htm.
3. ``Medical Instrumentation--Accessibility and Usability 
Considerations,'' Jack M. Winters and Molly Follette Story, eds., 
CRC Press, 2007.
4. ``Basic Statistics About Home Care,'' The National Association 
for Home Care and Hospice 2010, available at http://www.nahc.org/assets/1/7/10hc_stats.pdf.
5. ``CDRH Preliminary Internal Evaluations--Volume II: Task Force on 
the Utilization of Science in Regulatory Decision Making,'' August 
2010, p. 10, available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm220783.pdf.
6. ``CDRH Preliminary Internal Evaluations--Volume I: 510(k) Working 
Group Preliminary Report and Recommendations,'' FDA, August 2010, 
pp. 85-86, available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm220784.pdf.
7. ``510(k) and Science Report Recommendations: Summary and Overview 
of Comments and Next Steps,'' FDA, January 2011, available at http://www.fda.gov/downloads/aboutfda/centersoffices/cdrh/cdrhreports/ucm239449.pdf.
8. Transcript of April 7, 2011, public meeting, ``Medical Device Use 
in the Home Environment Workshop: Implications for the Safe and 
Effective Use of Medical Device Technology Migrating into the Home'' 
(May 24, 2011), available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm215636.htm.
9. ``Medical Device Labeling for Health Care Practitioners: Focus 
Group Study,'' RTI International, May 2011, OMB control number 0910-
0497, available at http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM335197.pdf.
10. ``Device Labeling Study: Practitioner Perspectives on Utility, 
Format, and Content of an Abbreviated Version of Labeling: Report 
Summary,'' RTI International, March 2013, OMB control number 0910-
0715, available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/ucm386369.htm.
11. ``Public Workshop--Medical Device Patient Labeling, September 
29-30, 2015'' available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm.
12. ``Preliminary Regulatory Impact Analysis, Initial Regulatory 
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for 
Electronic Submission of Labeling for Certain Home-Use Medical 
Devices,'' available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses//default.htm.

List of Subjects

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR part 807 be amended as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
1. The authority citation for part 807 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.


Sec.  807.26   [Amended]

0
2. Amend Sec.  807.26(e) introductory text by removing the word 
``only''.


Sec.  807.40   [Amended]

0
3. Amend Sec.  807.40(a) by removing the words ``subpart B'' and adding 
in their place ``subparts B and F''.
0
4. Add subpart F, consisting of Sec. Sec.  807.200 through 807.300, to 
read as follows:
Subpart F--Submission of Labeling When Listing Certain Home-Use Devices
Sec.
807.200 Home-use device definitions.
807.205 Submission of labeling required for listing certain home-use 
devices.
807.220 Voluntary submission of labeling for a home-use device.
807.300 When updated labeling for a home-use device must be 
submitted to FDA.

Subpart F--Submission of Labeling When Listing Certain Home-Use 
Devices


Sec.  807.200  Home-use device definitions.

    The definitions of this section apply only to this subpart and not 
for other purpose, including the categorization of in vitro diagnostic 
products under 42 CFR 493.15:
    Home-use device means a medical device that is labeled for use in 
any environment outside a professional health care facility.
    Package insert means all informational materials directed to the 
user of the device, and which are provided in a device package or which 
contemporaneously accompany the device when it is delivered to the 
user, including by electronic means.


Sec.  807.205  Submission of labeling required for listing certain 
home-use devices.

    Whenever this part requires the owner or operator of an 
establishment to submit listing information, and the listing concerns a 
home-use device regulated by the Center for Devices and Radiological 
Health as a class II or class III medical device, the owner or operator 
must submit the label and package insert of that home-use device by 
electronic means in a format specified by FDA that we can process, 
review, and archive. If a waiver from filing registration and listing 
information electronically has been obtained under Sec.  807.21(b), the 
label and package insert shall be submitted in the same manner as other 
registration and listing information, as directed by Sec.  807.34.


Sec.  807.220  Voluntary submission of labeling for a home-use device.

    (a) If listing a home-use device that is not regulated by the 
Center for Devices and Radiological Health as a class II or class III 
medical device, the owner or operator may submit the label and package 
insert for the device.
    (b) If a listing of a home-use device represents more than one 
product catalog or model number, the owner or operator may submit the 
label and package insert for each catalog or model number.
    (c) An owner or operator may submit the label and package insert 
for a home-use device that is not currently listed if that device was 
previously listed pursuant to this part but has been discontinued.

[[Page 71427]]

Sec.  807.300  When updated labeling for a home-use device must be 
submitted to FDA.

    (a) Whenever this part requires updated listing information to be 
submitted, and the updated listing concerns a home-use device regulated 
by the Center for Devices and Radiological Health as a class II or 
class III medical device, the owner or operator shall determine whether 
any change has been made to the labeling most-recently submitted to FDA 
for the device. If any change has been made to the most recently 
submitted labeling, the owner or operator shall submit the current 
labeling. If no change has been made to the most recently submitted 
labeling, the owner or operator shall provide a statement to that 
effect.
    (b) The owner or operator may voluntarily submit updated labeling 
for a listed device at any time prior to the time this part requires 
such labeling to be submitted.

    Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25026 Filed 10-14-16; 8:45 am]
 BILLING CODE 4164-01-P


