[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68334-68340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27047]


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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 Required in 
Electronic Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a final rule amending requirements for medical device premarket 
submissions to remove paper and multiple copies and replace them with 
requirements for a single submission in electronic format. 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.

DATES: This rule is effective January 15, 2020.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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. G609, Silver Spring, MD 20993, 301-796-6559, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to 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 medical device 
premarket submission program and create a more efficient submission 
program. Because a medical device premarket submission in electronic 
format is easily reproducible, 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

[[Page 68335]]

submitters caused by requiring additional copies.

B. Summary of the Major Provisions of the Final Rule

    Under this final rule, FDA is amending its regulations on medical 
device submissions to remove requirements for paper and multiple copies 
and replace them with requirements for a single submission in 
electronic format. This requirement for a single submission in 
electronic format applies to all submission types enumerated in section 
745A(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 379k-1); under this final rule, FDA is only amending those 
regulations that specifically mention paper and/or multiple copies of 
regulatory submissions and are not consistent with this final rule. 
Therefore, this final rule will amend regulations for the following 
submission types: Premarket Notification (510(k)) submissions (21 CFR 
807.90); Confidentiality of Information Certifications (21 CFR 807.95); 
Investigational Device Exemption (IDE) applications (21 CFR 812.20); 
Premarket Approval Applications (PMAs) (21 CFR 814.20); PMA supplements 
(21 CFR 814.39); and Humanitarian Device Exemption (HDE) Applications 
(21 CFR 814.104). These regulations cover both Center for Devices and 
Radiological Health (CDRH) and Center for Biologics Evaluation and 
Research (CBER) regulated devices. Submissions in electronic format 
include eCopies, submissions created and submitted on CD, DVD, or flash 
drive and mailed to FDA, and eSubmissions, submission package produced 
by an electronic submission template.
    This final rule will also amend sections of the regulations that 
identify FDA's mailing address for submissions and replace those 
addresses with a website address for CDRH and CBER that provides the 
current mailing addresses.

C. Legal Authority

    FDA is issuing this final 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, 360bbb-8b, 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 provides 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.

D. Costs and Benefits

    The final rule amends device regulations describing the number of 
copies firms must submit with a premarket presubmission or submission. 
The final rule also amends all device regulations containing a 
reference to the specific form of a submission to require a submission 
in electronic format. The final rule will produce cost savings for 
firms without imposing any additional regulatory burdens for 
submissions or affecting the Agency's ability to review 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 estimate that the final rule will result in annualized benefits 
of $1.76 million at a 3 percent discount rate and $1.76 million at a 7 
percent discount rate, over 10 years. We also estimate that the final 
rule will result in annualized costs of $0.75 million at a 3 percent 
discount rate and $0.87 million at a 7 percent discount rate, over 10 
years.

   II--Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
    Term,  abbreviation,  or acronym              What it means
------------------------------------------------------------------------
510(k).................................  Premarket Notification.
Agency.................................  Food and Drug Administration.
CFR....................................  Code of Federal Regulations.
eCopy..................................  Submissions created and
                                          submitted on CD, DVD, or flash
                                          drive and mailed to FDA.
eSubmissions...........................  Submission package produced by
                                          an electronic submission
                                          template.
EO.....................................  Executive Order.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act, 21 U.S.C. 301 et
                                          seq.
FDA....................................  Food and Drug Administration.
FDARA..................................  FDA Reauthorization Act of 2017
                                          (Pub. L. 115-52).
FDASIA.................................  Food and Drug Administration
                                          Safety and Innovation Act
                                          (Pub. L. 112-144).
HDE....................................  Humanitarian Device Exemption.
IDE....................................  Investigational Device
                                          Exemption
PMA....................................  Premarket Approval Application.
------------------------------------------------------------------------

II. Background

A. Need for the Regulation/History of the Rulemaking

    On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform 
Agenda'' 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 final rule.
    FDA's current medical device regulations that require multiple 
copies and paper submissions predate the authority provided to FDA in 
the FD&C Act to require submissions in electronic format (see 21 CFR 
parts 807, 812, and 814 and section 745A of the FD&C Act).
    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 would 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), and 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 
did 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

[[Page 68336]]

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)(3) of the FD&C Act 
and section 207 of FDARA). The amended provisions in the FD&C Act 
require presubmissions and submissions (the same types of submissions 
as required eCopies), 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).
    FDA is amending current medical device regulations that require 
multiple copies and paper submissions 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.
    In the Federal Register of September 13, 2018 (83 FR 46444), FDA 
issued a proposed rule entitled ``Medical Device Submissions: Amending 
Premarket Regulations That Require Multiple Copies and Specify Paper 
Copies To Be Allowed in Electronic Format'' and requested public 
comments by December 12, 2018.
    FDA believes this rule will result in meaningful burden reduction 
while allowing the Agency to achieve our public health mission and 
fulfill statutory obligations.

B. Summary of Comments to the Proposed Rule

    In response to the proposed rule, FDA received 14 comments--from 
industry organizations, individuals, and anonymous. The comments on the 
proposed rule were all generally supportive of the proposed amendments 
regarding submissions in electronic format. Commenters expressed that 
premarket submissions in electronic format will make the process more 
efficient, faster, lower the costs, and promote innovation as well as 
speed up accessibility for patient care. Commenters also noted that the 
submissions in electronic format will reduce paper, errors and allow 
storage and easy access to submissions. One of the commenters suggested 
including additional regulations for submissions in electronic format 
and recommended corresponding changes to the proposed amendments.

C. General Overview of the Final Rule

    FDA is issuing this final rule to amend regulations for medical 
device premarket submissions to remove the requirements for multiple 
copies of submissions and to instead require a single submission in 
electronic format. The revised submissions include premarket 
notification submissions (510(k) submissions) (Sec.  807.90); 
confidentiality of information certification (Sec.  807.95); 
investigational device exemption applications (Sec.  812.20); PMAs 
(Sec.  814.20), including PMA supplements (Sec.  814.39); and 
humanitarian device exemption applications (Sec.  814.104). This final 
rule also affects submissions for CBER regulated devices.
    This final rule will also amend the regulations that identify FDA's 
mailing addresses for submissions by replacing those addresses with 
website addresses for CDRH and CBER that provide the current mailing 
addresses.
    The submission of an eCopy is separate and distinct from FDA's 
electronic submission programs (eSubmitter), which include the CDRH's 
510(k) eSubmissions Pilot Program (79 FR 24732, May 1, 2014). 
Nevertheless, FDA considers both eCopies, submissions created and 
submitted on a CD, DVD, or flash drive and mailed to FDA, and 
eSubmissions, submission package produced by an electronic submission 
template, 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 Electronic Submission Gateway for the receipt and 
processing of many types of electronic regulatory submissions (Ref. 2).

IV. Legal Authority

    FDA is issuing this final 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, 360bbb-8b, 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 provides FDA authority 
with respect to electronic format for submissions and any appeals, and 
section 701(a) of the FD&C Act grants FDA general rulemaking authority 
to issue regulations for the efficient enforcement of the FD&C Act.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    In response to the proposed rule announcing FDA's intent 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, FDA received 14 comments--from 
industry organizations, individuals, and anonymous.
    We describe and respond to the comments in section V.B. We have 
numbered each comment to help distinguish between different comments. 
We have grouped similar comments under the same number for purposes of 
our responses. The number assigned to each comment or comment topic is 
purely for organizational purposes and does not signify the comment's 
value or importance or the order in which comments were received.

B. Description of Comments and FDA Response

    Several commenters made general remarks supporting the proposed 
rule without focusing on a particular proposed provision. In the 
following paragraphs, we discuss and respond to such general comments 
as well as more specific comments.
    (Comment 1) Several commenters were supportive of the 
implementation of the proposed amendments to regulations on medical 
device submissions to remove requirements for paper and multiple copies 
and replace them with requirements for a single submission in 
electronic format. The commenters suggested that single copy 
submissions in electronic format will be easier, improve efficiency of 
the review process, reduce paper, costs, errors, and support 
innovation. The commenters also suggested that submissions in 
electronic format will provide easy storage and access to records and 
reduce the time for creating the submissions. Most of the commenters 
did not suggest any further edits to the proposed rule. A commenter 
suggested assigning IDs or reference numbers to each product to

[[Page 68337]]

advance post market surveillance of medical devices.
    (Response 1) FDA agrees with the commenters that submission in 
electronic format will improve the efficiency with lower costs and 
easier storage and access to records. Regarding the comment related to 
the ID/reference numbers, FDA did not modify the final rule based on 
this comment as it is outside the scope of the requirement for a single 
submission in electronic format. Accordingly, in response to this 
comment, FDA did not make any changes in the final rule.
    (Comment 2) A commenter supported the implementation of the rule 
but also suggested that electronic submissions be made via the 
internet, in an Extensible Markup Language (XML) format. The commenter 
suggested that FDA should be developing specifications for industry 
submission authoring software that would integrate directly into FDA's 
review platform; the commenter explained that this type of submission 
authoring software could create elements of structured data within a 
submission.
    (Response 2) In response, FDA acknowledges the advantages of 
electronic submissions. FDA notes that the rule is written broadly 
enough to permit electronic submissions and allow for structured data 
when such platforms are available. Accordingly, we have made no change 
in the final rule.
    (Comment 3) A commenter suggested applying a logical and least 
burdensome approach in all FDA guidances, regulatory decisions, and 
administrative processes. The commenter further indicated that they 
supported removing paper and multiple copies and replacing them with a 
single submission in electronic format.
    (Response 3) FDA acknowledges this comment and agrees that the 
least burdensome principles should be considered in all FDA guidances, 
regulatory decisions and administrative processes (Ref. 3). FDA 
believes this final rule limits any burdens and expenses to submitters 
caused by requiring multiple copies of a submission. Accordingly, in 
response to this comment, FDA did not make any changes in the final 
rule.
    (Comment 4) A commenter acknowledged the benefits of the rule and 
supported implementation with a recommendation to amend the rule and 
include additional regulations within the scope and description of the 
rule. Specifically, the commenter proposed revising FDA's regulation 
for devices to remove the requirement for multiple copies of 
submissions and to instead require one electronic version for those 
regulations noted in the proposed rule in addition to the following: 
Content and format of a 510(k) summary (Sec.  807.92); content and 
format of a 510(k) statement (Sec.  807.93); format of a class III 
certification (Sec.  807.94); supplemental applications (Sec.  812.35); 
reports (Sec.  812.150); reports (Sec.  814.84); PMA amendments and 
submitted PMAs (Sec.  814.37); and post approval requirements and 
reports (Sec.  814.126).
    (Response 4) FDA agrees with the commenter that this rule should 
apply to all premarket regulatory submissions that are specified in 
section 745A(b) of the FD&C Act. The requirement for a single 
submission in electronic format applies to all submission types that 
fall within the provisions listed in section 745A(b) of the FD&C Act; 
under this final rule, FDA is only amending those regulations that 
specifically mention paper and/or multiple copies of such regulatory 
submissions and are not consistent with this final rule. Any 
regulations that are currently silent on the method for submitting such 
regulatory submissions to the FDA will not be modified as they remain 
consistent with the final rule. Accordingly, in response to this 
comment, FDA did not make any changes in the final rule.

VI. Effective Date

    The final rule will become effective 30 days after the date of 
publication in the Federal Register.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final 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 
final 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 final rule amends the existing premarket 
regulations requiring multiple copies and paper submissions to instead 
require submissions in electronic format without imposing any new 
requirements, we certify that the final 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 $154 million, using the most current (2018) Implicit 
Price Deflator for the Gross Domestic Product. This final rule will not 
result in an expenditure in any year that meets or exceeds this amount.
    This final rule will amend the device regulations describing the 
number of copies firms must submit with a premarket presubmission or 
submission. The final rule will also amend all device regulations 
containing a reference to the specific form of a submission media 
(i.e., paper copies) to require a submission in electronic format. The 
final rule will produce cost-savings for firms without imposing any 
additional regulatory burdens for submissions or affecting the Agency's 
ability to review 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 final Economic Analysis of 
Impacts that assesses the impacts of the final rule. The full analysis 
of economic impacts is available in the docket for this final rule 
(Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

Summary of Costs and Benefits

    Table 1 summarizes the benefits, costs, and distributional effects 
of the final rule. We estimate that the final rule will result in 
annualized net benefits of $1.76 million with a 3 percent discount rate 
and $1.76 million with a 7 percent discount rate, over 10 years. We 
also estimate that the final rule will result in annualized costs of 
$0.75 million at a 3 percent discount rate and $0.87 million at a 7 
percent discount rate, over 10 years.

[[Page 68338]]



                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/          $1.76       $0.63       $3.73        2017           7          10  Benefits are cost savings.
     year.                                    1.76        0.63        3.73        2017           3          10  Benefits are cost savings.
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/           0.87        0.87        0.87        2017           7          10
     year.                                    0.75        0.75        0.75        2017           3          10
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........           7  ..........
     $millions/year.                    ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........           7  ..........
     $millions/year.                    ..........  ..........  ..........  ..........           3  ..........
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in Table 2 we present annualized values of 
costs and cost savings over an infinite time horizon. With a 7 percent 
discount rate, the estimated annualized net cost-savings equal $1.31 
million in 2016 dollars over an infinite horizon. Based on these cost 
savings, this final rule, is considered a deregulatory action under 
E.O. 13771.

 Table 2--Summary of the Executive Order 13771 Impacts of the Final Rule
                      Over an Infinite Time Horizon
                            [2016 $ millions]
------------------------------------------------------------------------
                                              Primary         Primary
                                          estimate  (7%)  estimate  (3%)
------------------------------------------------------------------------
Present Value of Costs..................           $6.43           $6.43
Present Value of Cost Savings...........           26.45           59.40
Present Value of Net Costs..............         (20.01)         (52.97)
Annualized Costs........................            0.42            0.19
Annualized Cost Savings.................            1.73            1.73
Annualized Net Costs....................          (1.31)          (1.54)
------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., cost-
  savings).

VIII. 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.

IX. Paperwork Reduction Act of 1995

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

X. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in E.O. 13132. FDA has determined that the 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.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this final 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the

[[Page 68339]]

Executive Order and, consequently, a tribal summary impact statement is 
not required.

XII. 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/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
    2. Electronic Submission Gateway procedure for electronic 
regulatory submission is available at: https://www.fda.gov/industry/electronic-submissions-gateway/about-esg.
    3. ``The Least Burdensome Provisions: Concept and Principles; 
Guidance for Industry and Food and Drug Administration Staff'' 
available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
    4. Economic impacts analysis for this final rule available at: 
https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/medical-device-submissions-amending-premarket-regulations-require-multiple-copies-and-specify-paper.

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 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, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.


0
2. Amend Sec.  807.90 by revising paragraph (a), removing and reserving 
paragraph (b), and revising paragraph (c) to 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 to 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, 360bbb-8b, 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, 360c-360j, 360bbb-8b, 
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);

[[Page 68340]]

0
c. Removing the comma at the end of paragraph (b)(5)(i) and adding a 
semicolon in its place;
0
d. Revising paragraphs (c) and (e) introductory text;
0
e. Removing the commas at the ends of paragraphs (e)(1) and (2) and 
adding semicolons in their place; and
0
f. 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 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 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
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: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27047 Filed 12-13-19; 8:45 am]
 BILLING CODE 4164-01-P