[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Proposed Rules]
[Pages 46444-46449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19865]



[[Page 46444]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 812, and 814

[Docket No. FDA-2018-N-0628]
RIN 0910-AH48


Medical Device Submissions: Amending Premarket Regulations That 
Require Multiple Copies and Specify Paper Copies To Be Allowed in 
Electronic Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing to amend requirements for medical device premarket 
submissions to remove paper and multiple copies and replace them with 
requirements for a single submission in electronic format. If 
finalized, this action would reduce the number of copies in electronic 
format required, thus improving and making more efficient the FDA's 
premarket submission program for medical devices. This action is part 
of FDA's implementation of Executive Orders (EOs) 13771 and 13777. 
Under these EOs, FDA is comprehensively reviewing existing regulations 
to identify opportunities for repeal, replacement, or modification that 
will result in meaningful burden reduction while allowing the Agency to 
achieve our public health mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on this proposed 
rule by December 12, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 12, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-0628 for ``Medical Device Submissions: Amending Premarket 
Regulations that Require Multiple Copies and Specify Paper Copies to be 
Allowed in Electronic Format.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
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 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://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 https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Diane Garcia, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993, 301-796-6559, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
II. Background
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Economic Analysis of Impacts
 VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination with Indian Tribal Governments
XI. References

I. Executive Summary

    This proposed rule would amend regulations on medical device 
premarket submissions to remove requirements for paper and multiple 
copies and replace them with requirements for a single submission in 
electronic format to improve the FDA's premarket submission program for 
medical devices and to create a more efficient submission program. 
Because a medical device premarket submission in electronic format is 
easily reproducible,

[[Page 46445]]

and the requirement for multiple copies, whether in electronic format 
or paper form, is no longer necessary, FDA believes it is beneficial to 
the public to limit any burden and expense to submitters caused by 
requiring additional copies.

II. Background

    On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform 
Agenda'' (https://www.gpo.gov/fdsys/pkg/FR-2017-03-01/pdf/2017-04107.pdf, 82 FR 12285 (March 1, 2017)) was issued. One of the 
provisions in the E.O. requires Agencies to evaluate existing 
regulations and make recommendations to the Agency head regarding their 
repeal, replacement, or modification, consistent with applicable law. 
As part of this initiative, FDA is updating regulations as specified in 
this proposed rule.
    FDA's current medical device regulations that require multiple 
copies and paper submissions predate the authority provided to FDA in 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require 
electronic submissions (see 21 CFR parts 807, 812, and 814 and section 
745A of the FD&C Act (21 U.S.C. 379k-1)).
    The FD&C Act was amended by the Food and Drug Administration Safety 
and Innovation Act (FDASIA) (Pub. L. 112-144) (see section 745A(b) of 
the FD&C Act and section 1136 of FDASIA). The amendments in FDASIA 
provided that after FDA issued guidance on the submission of electronic 
copies (eCopies), the submission of eCopies will be required for 
presubmissions and submissions and any supplements to these 
presubmissions and submissions for medical devices. (For sections 
requiring submission, see sections 510(k), 513(f)(2)(A), 515(c), (d) 
and (f), 520(g) and (m), or 564 of the FD&C Act (21 U.S.C. 360(k), 
360c(f)(2)(A), 360e(c), (d) and (f), 360j(g) and (m), and 360bbb-3 or 
section 351 of the Public Health Service Act (42 U.S.C. 262).) Congress 
granted explicit statutory authorization to FDA to implement eCopy 
requirements by providing through guidance the standards and criteria 
for waivers and exemptions (section 745(b)(1) and (2) of the FD&C Act).
    On January 2, 2013, FDA published the guidance entitled ``eCopy 
Program for Medical Device Submissions'' (eCopy guidance). The issuance 
of the eCopy guidance marked the beginning of the eCopy program. The 
2013 guidance was superseded by an updated guidance of the same title 
issued on December 3, 2015. The eCopy guidance recommends that one 
paper copy should be submitted, and that any additional copies required 
under the regulations be submitted as eCopies. While the eCopy guidance 
does not change the overall number of copies required for any 
submission, the guidance states that eCopies should be provided in lieu 
of some of the paper copies. The guidance also outlines other 
requirements for eCopies. The eCopy guidance provides instructions for 
the processing and technical standards for eCopies based on FDA's 
experience with the program (Ref. 1).
    In 2017, the FD&C Act was amended by the FDA Reauthorization Act of 
2017 (FDARA) (Pub. L. 115-52) (see section 745A(b) of the FD&C Act and 
section 207 of FDARA). The amended provisions in the FD&C Act require 
presubmissions and submissions, any supplements to such presubmissions 
or submissions for devices, and any appeals of action taken with 
respect to such presubmissions or submissions, including devices under 
the Public Health Service Act to be submitted solely in electronic 
format as specified by FDA in guidance (section 745A(b)(3) of the FD&C 
Act).

III. Legal Authority

    FDA is issuing this proposed rule from the same authority under 
which FDA initially issued these regulations: 21 U.S.C. 321, 331, 351, 
352, 353, 355, 360, 360h-360j, 360c-360j, 371, 372, 373, 374, 375, 379, 
379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264, 271. In 
addition, section 745A of the FD&C Act and section 207 of FDARA provide 
FDA authority with respect to electronic format for submissions and any 
appeals, and section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants 
FDA general rulemaking authority to issue regulations for the efficient 
enforcement of the FD&C Act.

IV. Description of the Proposed Rule

    We are proposing to revise FDA's regulations for devices to remove 
the requirements for multiple copies of submissions and to instead 
require one electronic version. The affected submissions include 
premarket notification submissions (510(k) submissions) (21 CFR 
807.90), including confidentiality of information certification (21 CFR 
807.95); investigational device exemption applications (21 CFR 812.20); 
premarket approval applications (PMA) (21 CFR 814.20), including PMA 
supplements (21 CFR 814.39); and humanitarian device exemption 
applications (21 CFR 814.104). This proposed rule also affects 
submissions for Center for Biologics Evaluation and Research (CBER) 
regulated devices.
    Another amendment that the proposed rule will make, if finalized, 
is to the sections of the regulations that identify FDA's mailing 
addresses for submissions. Current regulations include specific mailing 
addresses for submissions. If a mailing address needs to be updated, 
this necessitates an amendment to the regulations to update that 
address. A simpler and more efficient means of providing current 
mailing addresses is to create a website that can list current mailing 
addresses. Any changes to mailing addresses can be added to the website 
without the need for an amendment to the regulations. This proposed 
rule will amend the regulations to remove the mailing addresses for 
submissions and replace those addresses with a website address for the 
Center for Devices and Radiological Health (CDRH) and CBER.
    The submission of an eCopy is separate and distinct from FDA's 
electronic submission programs (eSubmitter), which include the 
Electronic Submission Gateway (ESG) and CDRH's 510(k) eSubmissions 
Pilot Program (79 FR 24732, May 1, 2014). Nevertheless, FDA considers 
both to be submissions in electronic format. While eCopy provides for 
submissions to be in electronic format, the eCopy submissions must 
still be mailed to FDA. By contrast, eSubmitter allows for electronic 
submissions to be transmitted over the internet. FDA has been moving 
toward transforming all regulatory submissions from mailed copies to 
electronic means via the internet. Since January 1999, FDA has accepted 
voluntary electronic submissions through eSubmitter. FDA presently 
utilizes the ESG for the receipt and processing of many types of 
electronic regulatory submissions (Ref. 2). FDA considers eCopies, 
submissions copied to a CD, DVD, or flash drive and mailed to FDA, and 
eSubmissions, to be submissions in electronic format.
    These changes are intended to improve the efficiency of the review 
process by allowing immediate availability of an electronic version for 
review, rather than relying solely on the paper version. Because a 
submission in electronic format is easily reproducible, the requirement 
for multiple copies (whether in electronic format or paper form) is no 
longer necessary. Furthermore, FDA believes it is beneficial to the 
public to limit any burdens and expenses to submitters caused by 
requiring additional copies.
    FDA is proposing to amend current medical device regulations that 
require multiple copies and paper submissions

[[Page 46446]]

(21 CFR parts 807, 812, and 814). FDA is taking this action because the 
requirement for multiple copies (whether in electronic format or paper 
form) listed in the regulation is no longer necessary, and it is 
beneficial to the public to limit any burden and expense to submitters 
caused by requiring additional copies.

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become 
effective 30 days after the date of publication of a final rule in the 
Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866, 
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
E.O.s 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). E.O. 13771 requires that 
the costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' We believe that this 
proposed rule is not a significant regulatory action as defined by E.O. 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the proposed rule amends the existing premarket 
regulations requiring multiple copies and paper submissions to 
electronic format submissions without imposing any new requirements, we 
propose to certify that the proposed rule will not have a significant 
economic impact on a substantial number of small entities.
    The Unfunded Mandate's 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 $150 million, using the most current (2017) 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.
    The purpose of this proposed rule is to amend device regulations 
requiring that firms submit a specific number of copies with a 
premarket presubmission or submission to a single submission in 
electronic form. The proposed rule also amends all device regulations 
containing references to submission media (i.e., paper copies) to a 
submission in electronic form. The amendment will produce cost savings 
for firms without imposing any additional regulatory burdens for 
submissions. Firms will incur minimal administrative costs to read and 
understand the rule. We expect the economic impact of this regulation 
to be a total net costs savings yielding positive net benefits.
    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
analysis of economic impacts is available in the docket for this 
proposed rule (Ref. 3) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

Summary of Costs and Benefits

    The proposed rule, if finalized, would amend device regulations 
requiring the number of copies firms must submit with a premarket 
presubmission or submission. The proposed rule would also amend all 
device regulations containing a reference to the specific form of a 
submission to require an electronic submission. The amendment would 
produce cost savings for firms without imposing any additional 
regulatory burdens for submissions or affecting the Agency's ability to 
review submissions. Firms would incur minimal administrative costs to 
read and understand the rule. We expect the economic impact of this 
regulation to be a total net costs savings yielding positive net 
benefits.
    Table 1 summarizes the benefits, costs, and distributional effects 
of the proposed rule. We find that the proposed rule would result in 
annualized net benefits in the form of cost savings of around $2.80 
million with a 3 percent discount rate and $2.71 million with a 7 
percent discount rate.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Units
             Category                   Primary      Low estimate    High estimate ------------------------------------------------         Notes
                                       estimate                                      Year dollars    Discount rate  Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized....................           $3.37           $1.31           $5.47            2016              7%        10 years  Benefits are cost
                                                                                                                                     savings.
    Monetized $millions/year......           $3.37           $1.31           $5.47            2016              3%        10 years  Benefits are cost
                                                                                                                                     savings.
    Annualized....................  ..............  ..............  ..............  ..............              7%  ..............  ....................
    Quantified....................  ..............  ..............  ..............  ..............              3%  ..............  ....................
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  ....................
Costs:
    Annualized....................           $0.67           $0.67           $0.67            2016              7%        10 years  ....................
    Monetized $millions/year......           $0.57           $0.57           $0.57            2016              3%        10 years  ....................
    Annualized....................  ..............  ..............  ..............  ..............              7%  ..............  ....................
    Quantified....................  ..............  ..............  ..............  ..............              3%  ..............  ....................
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  ....................
Transfers:
    Federal Annualized............  ..............  ..............  ..............  ..............              7%  ..............  ....................
    Monetized $millions/year......  ..............  ..............  ..............  ..............              3%  ..............  ....................
                                   ---------------------------------------------------------------------------------------------------------------------

[[Page 46447]]

 
    From/To.......................  From:
                                    To:
                                   ---------------------------------------------------------------------------------------------------------------------
    Other Annualized..............  ..............  ..............  ..............  ..............              7%  ..............  ....................
                                   ---------------------------------------------------------------------------------------------------------------------
    Monetized $millions/year......  ..............  ..............  ..............  ..............              3%  ..............  ....................
    From/To.......................  From:
                                    To:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 2 summarizes the E.O. 13771 impacts of the proposed rule. 
Over an infinite time horizon, the present value of the total net costs 
would range from $40.01 million to $182.94 million at a 3 percent 
discount rate and from $15.04 million to $78.67 million at a 7 percent 
discount rate. Over an infinite time horizon, the total annualized net 
costs would range from $1.17 million to $5.33 million at a 3 percent 
discount rate, and range from $0.98 million to $5.15 million at a 7 
percent discount rate. This proposed rule, if finalized, is considered 
an Executive Order 13771 deregulatory action.

                        Table 2--Summary of the Executive Order 13771 Impacts of the Proposed Rule Over an Infinite Time Horizon
                                                                    [2016 $ millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Primary       Lower bound     Upper bound       Primary       Lower bound     Upper bound
                                                           estimate (3%)       (3%)            (3%)        estimate (7%)       (7%)            (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $5.01           $5.01           $5.01           $5.01           $5.01           $5.01
Present Value of Cost Savings...........................          115.79           45.02          187.95           51.55           20.04           83.68
Present Value of Net Costs..............................        (110.78)         (40.01)        (182.94)         (46.54)         (15.04)         (78.67)
Annualized Costs........................................            0.15            0.15            0.15            0.33            0.33            0.33
Annualized Cost Savings.................................            3.37            1.31            5.47            3.37            1.31            5.47
Annualized Net Costs....................................          (3.23)          (1.17)          (5.33)          (3.04)          (0.98)          (5.15)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e. cost-savings).

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.34(a) 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. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information subject to review by the Office of Management 
and Budget under the Paperwork Reduction Act of 1995. Rather, it 
proposes to remove requirements to submit multiple paper copies of 
certain medical device presubmissions and submissions and to replace 
them with one copy in an electronic format.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. We have determined that this 
proposed rule does not contain policies that 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 conclude that the rule does not contain policies that have 
federalism implications as defined in the E.O. and, consequently, a 
federalism summary impact statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have determined that the rule 
does not contain policies that would have a substantial direct effect 
on one or more Indian Tribes, on the relationship between the Federal 
Government and Indian Tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian Tribes. The 
Agency solicits comments from tribal officials on any potential impact 
on Indian Tribes from this proposed action.

XI. References

    The following references are on display at Dockets Management Staff 
(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 https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. ``eCopy Program for Medical Device Submissions; Guidance for 
Industry and Food and Drug Administration Staff'' available at: 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf.
2. Electronic Submission Gateway procedure for electronic regulatory 
submission is available at: https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.
3. Preliminary economic impacts analysis for this proposed rule 
available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

[[Page 46448]]

List of Subjects

21 CFR Part 807

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

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, 21 CFR 
parts 807, 812, and 814 are proposed to 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 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.

0
2. In Sec.  807.90, revise paragraph (a), remove and reserve paragraph 
(b), and revise paragraph (c).
    The revisions read as follows:


Sec.  807.90   Format of a premarket notification submission.

* * * * *
    (a)(1) For devices regulated by the Center for Devices and 
Radiological Health, be addressed to the current address displayed on 
the website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, be addressed to the current address displayed on the 
website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm; or for devices 
regulated by the Center for Drug Evaluation and Research, be addressed 
to the Central Document Room, Center for Drug Evaluation and Research, 
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 
20705-1266. Information about devices regulated by the Center for 
Biologics Evaluation and Research is available at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.
    (3) All inquiries regarding a premarket notification submission 
should be sent the address in this section or one of the current 
addresses displayed on the Food and Drug Administration's website.
* * * * *
    (c) Be submitted as a single version in electronic format.
* * * * *
0
3. Amend Sec.  807.95 by revising paragraph (b)(1) introductory text to 
read as follows:


Sec.  807.95  Confidentiality of information.

* * * * *
    (b) * * *
    (1) The person submitting the premarket notification submission 
requests in the submission that the Food and Drug Administration hold 
as confidential commercial information the intent to market the device 
and submits a certification to the Commissioner:
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
4. The authority citation for part 812 is revised to read as follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 
216, 241, 262, 263b-263n.

0
5. Amend Sec.  812.19 by revising paragraphs (a)(1) and (2) to read as 
follows:


Sec.  812.19  Addresses for IDE correspondence.

    (a) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, send it to the current address displayed on the 
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, send it to the current address displayed on the website 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
0
6. Amend Sec.  812.20 by revising paragraph (a)(3) to read as follows:


Sec.  812.20  Application.

    (a) * * *
    (3) A sponsor shall submit a signed ``Application for an 
Investigational Device Exemption'' (IDE application), together with 
accompanying materials in electronic format, to one of the addresses in 
Sec.  812.19, and if eCopy by registered mail or by hand. Subsequent 
correspondence concerning an application or a supplemental application 
shall be submitted in electronic format and if eCopy by registered mail 
or by hand.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
7. The authority citation for part 814 is revised to read as follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360bbb-8b, 360c-360j, 
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

0
8. Amend Sec.  814.20 by:
0
a. Revising paragraph (b) introductory text and paragraph (b)(2);
0
b. Removing the phrase ``of the act'' and adding in its place ``of the 
Federal Food, Drug, and Cosmetic Act'' in paragraphs (b)(5) 
introductory text, (b)(5)(i), and (b)(10);
0
c. Revising paragraph (c);
0
d. Revising paragraph (e) introductory text; and
0
e. Revising paragraphs (f) and (h)(1) and (2).
    The revisions read as follows:


Sec.  814.20  Application.

* * * * *
    (b) Unless the applicant justifies an omission in accordance with 
paragraph (d) of this section, a PMA shall include in electronic 
format:
* * * * *
    (2) A table of contents that specifies the volume and page number 
for each item referred to in the table. A PMA shall include separate 
sections on nonclinical laboratory studies and on clinical 
investigations involving human subjects. A PMA shall be submitted as a 
single version. The applicant shall include information that it 
believes to be trade secret or confidential commercial or financial 
information in the PMA and identify the information that it believes to 
be trade secret or confidential commercial or financial information.
* * * * *
    (c) Pertinent information in FDA files specifically referred to by 
an applicant may be incorporated into a PMA by reference. Information 
in a master file or other information submitted to FDA by a person 
other than the applicant will not be considered part of a PMA unless 
such reference is authorized in a record submitted to FDA by the person 
who submitted the information or the master file. If a master file is 
not referenced within 5 years after the date that it is submitted to 
FDA, FDA will return the master file to the person who submitted it.
* * * * *
    (e) The applicant shall periodically update its pending application 
with

[[Page 46449]]

new safety and effectiveness information learned about the device from 
ongoing or completed studies that may reasonably affect an evaluation 
of the safety or effectiveness of the device or that may reasonably 
affect the statement of contraindications, warnings, precautions, and 
adverse reactions in the draft labeling. The update report shall be 
consistent with the data reporting provisions of the protocol. The 
applicant shall submit any update report in electronic format and shall 
include in the report the number assigned by FDA to the PMA. These 
updates are considered to be amendments to the PMA. The time frame for 
review of a PMA will not be extended due to the submission of an update 
report unless the update is a major amendment under Sec.  814.37(c)(1). 
The applicant shall submit these reports--
* * * * *
    (f) If a color additive subject to section 721 of the Federal Food, 
Drug, and Cosmetic Act is used in or on the device and has not 
previously been listed for such use, then, in lieu of submitting a 
color additive petition under part 71 of this chapter, at the option of 
the applicant, the information required to be submitted under part 71 
may be submitted as part of the PMA. When submitted as part of the PMA, 
the information shall be submitted in electronic format. A PMA for a 
device that contains a color additive that is subject to section 721 of 
the Federal Food, Drug, and Cosmetic Act will not be approved until the 
color additive is listed for use in or on the device.
* * * * *
    (h) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, send it to the current address displayed on the 
website http://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, send it to the current address displayed on the website 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
0
9. Amend Sec.  814.39 by revising paragraph (c)(1) to read as follows:


Sec.  814.39  PMA supplements.

* * * * *
    (c)(1) All procedures and actions that apply to an application 
under Sec.  814.20 also apply to PMA supplements except that the 
information required in a supplement is limited to that needed to 
support the change. A summary under Sec.  814.20(b)(3) is required for 
only a supplement submitted for new indications for use of the device, 
significant changes in the performance or design specifications, 
circuits, components, ingredients, principles of operation, or physical 
layout of the device, or when otherwise required by FDA. The applicant 
shall submit a PMA supplement in electronic format and shall include 
information relevant to the proposed changes in the device. A PMA 
supplement shall include a separate section that identifies each change 
for which approval is being requested and explains the reason for each 
such change. The applicant shall submit additional information, if 
requested by FDA, in electronic format. The time frames for review of, 
and FDA action on, a PMA supplement are the same as those provided in 
Sec.  814.40 for a PMA.
* * * * *
0
10. Amend Sec.  814.104 by revising paragraphs (d) introductory text 
and (d)(1) and (2) to read as follows:


Sec.  814.104  Original applications.

* * * * *
    (d) Address for submissions and correspondence. All original HDEs, 
amendments and supplements, as well as any correspondence relating to 
an HDE, must be provided in electronic format. These materials must be 
sent or delivered to one of the following:
    (1) For devices regulated by the Center for Devices and 
Radiological Health, send it to the current address found on the 
website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, send it to the current address displayed on the website 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *

    Dated: September 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-19865 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


