
[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)]
[Notices]
[Pages 21743-21744]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1037]


Pilot Program for Center for Devices and Radiological Health 
Electronic Submission for Home Use Device Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) Center for Devices and 
Radiological Health (CDRH) is announcing the availability of a CDRH 
electronic submissions Pilot Program database to house labeling for 
home use devices. Participation in the pilot is open to applicants who 
label their device(s) for home use. Participation in the pilot project 
is voluntary. Participants will be asked to navigate through the 
electronic submissions system and practice submitting labels and 
package inserts. The pilot project is intended to provide industry and 
CDRH staff the opportunity to evaluate the submissions process and 
system and to receive comments from industry participants.

DATES: FDA will accept applications for participation in the voluntary 
electronic submissions CDRH Home Use Device Labeling Pilot Program from 
May 1, 2015, through May 31, 2015. See the ``Participation'' section 
for instructions on how to submit a request to participate. The pilot 
project will occur July 1, 2015, through December 31, 2015.

FOR FURTHER INFORMATION CONTACT: Mary Weick-Brady, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66 Rm. 5426, Silver Spring MD 20993, 301-796-
6089, Mary.Brady@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is responsible for ensuring that medical devices are safe and 
effective when used for their intended purpose. Risks are inherent in 
all CDRH-regulated medical devices, and the Center plays a critical 
role in preventing injuries and deaths related to product use. CDRH 
minimizes risk through regulation, enforcement, and education. Risk 
minimization is accomplished, in part, through clear communication on 
the benefits and risks of the medical devices regulated by the Center, 
including communications by CDRH, product manufacturers, and product 
distributors. These communications include medical device labeling 
produced by manufacturers and distributors.
    Medical device labeling provides safety information, instructions 
for use, and/or other necessary information to the user. This labeling 
can be essential for home-use devices, which 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. When used in an environment where a healthcare professional is 
not available to provide supervision and assistance, these devices can 
present unique concerns and challenges. 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. In 
contrast with use in professional healthcare 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.
    Home-use devices have significant public health importance to 
patients, caregivers, and healthcare professionals. Therefore, it is 
necessary to ensure that users are able to access necessary information 
for use, including safety information and instructions for use. 
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. Web sites 
also vary considerably in the types of information provided and may 
lack important details concerning their devices. Although some 
manufacturers'

[[Page 21744]]

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.

II. CDRH Home Use Device Labeling Pilot

    CDRH is developing an electronic submissions database, accessible 
to the public through FDA's Web site, of labels and package inserts for 
listed home-use devices. This database would fill an important gap in 
the information available to patients, caregivers, and the healthcare 
community concerning home-use devices. The database 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.
    This electronic submissions database will be evaluated for 
usability through the CDRH Home Use Device Labeling Pilot Project. This 
pilot project will proceed for 6 months. Participation in the pilot is 
open to applicants who label their device(s) for home use. Participants 
will be asked to navigate through the electronic submissions system and 
practice submitting labels and package inserts. The pilot project is 
intended to provide industry and CDRH staff the opportunity to evaluate 
the submissions process and system and to receive comments from 
industry participants. Comments received during the pilot project will 
be used to evaluate the usability of the database. FDA will not review 
the content of any labeling submitted to the pilot database for a 
regulatory purpose. The submitted labeling and the database will only 
be available to pilot participants.

A. Participation

    Volunteers interested in participating in the pilot project should 
contact pilot staff by email at Mary.Brady@fda.hhs.gov. The following 
information should be included in the request: Contact name, contact 
phone number, and contact email address. FDA will contact interested 
applicants to discuss the pilot project. FDA is seeking a limited 
number of participants (no more than nine) to participate in this pilot 
project.

B. Procedures

    By following a series of prompts and instructions, pilot 
participants will submit a PDF version of their device labeling to the 
pilot database. The content of the submissions will not be reviewed by 
FDA for any regulatory purpose, nor will the pilot database be 
available to the public during this pilot project. During the pilot, 
CDRH staff will be available to answer any questions or concerns that 
may arise. Pilot project participants will be asked to comment on and 
discuss their experiences with the pilot submissions process. Their 
comments and discussions will assist CDRH in its development of this 
electronic submissions database.

III. Duration of the Home Use Device Labeling Pilot

    FDA intends to accept requests for participation in the Home Use 
Device Labeling Pilot from May 1, 2015, through May 31, 2015. The pilot 
will proceed for 6 months, from July 1, 2015, through December 31, 
2015. This pilot program may be extended as resources and needs allow.

IV. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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). The 
collections of information in 21 CFR parts 801 and 809 have been 
approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit electronic comments regarding the 
Home Use Device Labeling Pilot to http://www.regulations.gov or written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is 
only necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday and will be posted to 
the docket at http://www.regulations.gov.

    Dated: April 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08957 Filed 4-17-15; 8:45 am]
 BILLING CODE 4164-01-P


