Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications

 
CONTENT
Federal Register, Volume 84 Issue 242 (Tuesday, December 17, 2019)
[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Proposed Rules]
[Pages 68829-68833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27045]
[[Page 68829]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. FDA-2019-N-3101]
Revised Procedures for the Announcement of Approvals and Denials
of Premarket Approval Applications and Humanitarian Device Exemption
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend the medical device regulations regarding the
procedures for the announcement of approvals and denials of premarket
approval applications (PMAs) and humanitarian device exemption
applications (HDEs). We are proposing to discontinue publishing in the
Federal Register after each quarter a list of PMA and HDE approvals and
denials announced in that quarter. We will continue to post approval
and denial notices for PMAs and HDEs on FDA's home page on the internet
and will also continue to make available on the internet and place on
public display summaries of safety and effectiveness data (SSED) for
PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA
is proposing to take this action to improve the efficiency of
announcing approvals and denials of PMAs and HDEs and to eliminate
duplication in the current process for announcing this information. We
are also proposing to update Agency contact information and statutory
references in certain sections of the PMA and HDE regulations for
purposes of accuracy, clarity, and consistency.
DATES: Submit either electronic or written comments on the proposed
rule by March 2, 2020.
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 March 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 2, 2020. 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-2019-N-3101 for ``Revised Procedures for the Announcement of
Approvals and Denials of Premarket Approval Applications and
Humanitarian Device Exemption Applications.'' 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.govinfo.gov/content/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:
    For information concerning the proposed rule as it relates to
devices regulated by the Center for Biologics Evaluation and Research:
Jessica Walker Udechukwu, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
    For information concerning the proposed rule as it relates to
devices regulated by the Center for Devices and Radiological Health:
Joshua Nipper, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650,
Silver Spring, MD 20993-0002, 301-796-6524.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
[[Page 68830]]
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. History of the Rulemaking
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference
I. Executive Summary
A. Purpose of the Proposed Rule
    FDA is proposing to amend its medical device regulations regarding
the procedures for the announcement of approvals and denials of PMAs
and HDEs to discontinue the quarterly publication in the Federal
Register of a list of approvals and denials of both PMAs and HDEs. FDA
will continue to post approval and denial notices for PMAs and HDEs on
FDA's home page on the internet (https://www.fda.gov) and will also
continue to make available on the internet and place on public display
SSED for PMAs and SSPB for HDEs. FDA is proposing to take this action
to improve the efficiency of announcing approvals and denials of PMAs
and HDEs and eliminate duplication in the current process for
announcing this information. We are also proposing to update Agency
contact information and statutory references in certain of the PMA and
HDE regulations for purposes of accuracy, clarity, and consistency.
B. Summary of the Major Provisions of the Proposed Rule
    FDA is proposing to amend its regulations regarding the
announcement procedures for the approval and denial of PMAs and HDEs.
FDA is proposing to discontinue publishing in the Federal Register
after each quarter a list of PMA and HDE approvals and denials
announced for that quarter. We will continue to post approval and
denial notices for PMAs and HDEs on FDA's home page on the internet,
and we will also continue to make SSED for PMAs and SSPB for HDEs
available on the internet and place them on public display.
C. Legal Authority
    FDA is issuing this proposed rule under sections 515, 520(h),
520(m), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360e, 360j(h), 360j(m), and 371(a)).
D. Costs and Benefits
    The benefit of this proposed rule, if finalized, is that it would
result in cost savings to FDA from discontinuing publishing in the
Federal Register on a quarterly basis, a list of medical device PMA and
HDE approvals and denials. Annualized over 10 years, the estimated
benefits (i.e., cost savings) to FDA would range from $0.008 million to
$0.013 million at both 3 and 7 percent discount rate, with a primary
estimate of $0.010 million. This proposed rule, if finalized, would
result in no costs to industry because the rule would not require
performance of any additional tasks and, therefore, would not impose
any additional regulatory burden on the industry.
II. Background
A. Need for the Regulation
    FDA is proposing to amend its medical device regulations regarding
the procedures for the announcement of approvals and denials of PMAs
and HDEs to discontinue the quarterly publication in the Federal
Register of a list of approvals and denials of both PMAs and HDEs. FDA
is proposing to take this action to improve the efficiency of
announcing approvals and denials of PMAs and HDEs and eliminate
duplication in announcing this information. The proposed rule, if
finalized, would allow FDA staff to focus on other Agency priorities
and utilize FDA staff resources more efficiently. FDA is also proposing
to revise Sec.  814.44(d)(2) (21 CFR 814.44(d)(2)) to be consistent
with Sec.  814.45(d)(2) (21 CFR 814.45(d)(2)), which states that
requests for copies of the current PMA approvals and denials document
and copies of SSED must be sent in writing to FDA's Freedom of
Information Staff. In addition, FDA is proposing to update outdated
references to section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.
814.40 (21 CFR 814.40), 814.44, and 814.45) and HDE (Sec.  814.118 (21
CFR 814.118)) regulations.
B. History of the Rulemaking
    Section 515(d)(4) of the FD&C Act permits an interested person to
obtain review of an order approving a PMA in accordance with section
515(g) of the FD&C Act. The statute does not require the Agency to
publish the approval of a PMA in the Federal Register; however, FDA
issued in the Federal Register of July 22, 1986 (51 FR 26342) a final
rule that provided, among other things, that notice of approval of a
PMA, notice of an order denying approval of a PMA, and notice of an
order withdrawing approval of a PMA will be published in the Federal
Register. In the Federal Register of June 26, 1996 (61 FR 33232), FDA
issued a final rule prescribing, among other things, the procedures for
submitting HDEs, HDE amendments, and HDE supplements, and the criteria
for FDA review and approval of HDEs. Furthermore, the final rule of
June 26, 1996, provided that the notice of approval of an HDE be
published in the Federal Register in accordance with the rules and
policies applicable to PMAs submitted under 21 CFR 814.20. That final
rule also provided that, if FDA issues an order denying approval of an
HDE, FDA will comply with the same notice and disclosure provisions
required for PMAs under Sec.  814.45(b) and (d), as applicable.
    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
issued a final rule discontinuing the publication of individual PMA
approvals and denials in the Federal Register. The final rule provided
that FDA would notify the public of PMA approvals and denials by
posting them on FDA's home page on the internet, by placing SSED on the
internet and in FDA's Dockets Management Branch, and by publishing in
the Federal Register after each quarter a list of the PMA approvals and
denials announced in that quarter. FDA stated that it believed that
this procedure would expedite public notification of these actions
because announcements could be placed on the internet more quickly than
they could be published in the Federal Register, and FDA believed that
the internet would be accessible to more people than the Federal
Register.
III. Legal Authority
    We are issuing this proposed rule under the authority of sections
515, 520(h), and 520(m) of the FD&C Act, which set forth requirements
for device premarket approval, release of detailed summaries of
information respecting the safety and effectiveness of devices, and
humanitarian device exemptions, and under section 701(a) of the FD&C
Act, which provides FDA the authority to issue regulations for the
efficient enforcement of the FD&C Act.
IV. Description of the Proposed Rule
    We are proposing to amend 21 CFR part 814 to revise the PMA and HDE
approval and denial announcement procedures.
    FDA would discontinue publishing in the Federal Register after each
quarter a list of PMA and HDE approvals and denials announced in that
quarter (see proposed revisions to Sec. Sec.  814.44, 814.45, and
814.116). FDA will continue to give the public notice of PMA and HDE
[[Page 68831]]
approvals and denials by placing notices of approval and denial on
FDA's home page on the internet. Notices of PMA and HDE approval will
continue to include a notice of opportunity for interested persons to
request review. FDA considers the 30-day period for requesting
reconsideration of an FDA action under Sec.  10.33(b) (21 CFR 10.33(b))
for notices of PMA and HDE approval to begin on the day the notice is
placed on the internet. Section 10.33(b) provides that FDA may, for
good cause, extend this 30-day filing period. In addition, we will
continue to make available on the internet and place on public display
SSED and SSPB.
    We are also proposing to revise Sec.  814.44(d)(2), regarding
requests for copies of the current PMA approvals and denials document
and copies of SSED, to state that such requests must be sent to the
Freedom of Information Staff, rather than to the Division of Dockets
Management. We are proposing this revision because these requests are
currently handled by the Freedom of Information Staff. Revised Sec.
814.44(d)(2) would be consistent with current Sec.  814.45(d)(2).
    In addition, FDA is proposing to update outdated references to
section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.  814.40,
814.44, and 814.45) and HDE (Sec.  814.118) regulations. FDA is
proposing to make this update because section 515(d)(3) of the FD&C Act
was redesignated as section 515(d)(4) by section 202 of the Food and
Drug Administration Modernization Act of 1997 (Pub. L. 105-115).
V. Proposed Effective Date
    FDA is proposing that any final rule based on this proposed rule
become effective 30 days after the date of its publication in the
Federal Register.
VI. Preliminary Economic Analysis of Impacts
A. Introduction
    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 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 Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this proposed rule, if finalized, would not impose
any additional regulatory burden on the industry, we propose to certify
that the proposed rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
B. Summary of Benefits and Costs
    The benefit of this proposed rule, if finalized, is that it would
result in cost savings to FDA from discontinuing publishing in the
Federal Register, on a quarterly basis, a list of medical device PMA
and HDE approvals and denials. Discontinuing publishing Federal
Register notices with these approval and denial lists would eliminate
duplication in announcing this information; information on these
approvals and denials would continue being readily available to the
public on FDA's home page on the internet (https://www.fda.gov). We
estimate no additional benefits beyond these cost savings to FDA.
    We estimate that this proposed rule, if finalized, would result in
no additional costs to industry because the rule would not require
performance of any additional tasks. This proposed rule, therefore,
would not impose any additional regulatory burden on the industry.
    Table 1 summarizes the estimated benefits and costs of the proposed
rule, if finalized. Annualized over 10 years, the estimated benefits
(i.e., cost savings) of the proposed rule, if finalized, would range
from $0.008 million to $0.013 million at both 3 and 7 percent discount
rate, with a primary estimate of $0.010 million. The present value of
the estimated benefits (i.e., cost savings) of the proposed rule, if
finalized, would range from $0.068 million to $0.111 million at a 3
percent discount rate and from $0.056 million to $0.091 million at a 7
percent discount rate. The annualized costs of the proposed rule, if
finalized, would be $0 at both 3 and 7 percent discount rate. The
present value of costs of the proposed rule, if finalized, would also
be $0 at both 3 and 7 percent discount rate.
                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate  (%)    (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/         $0.010      $0.008      $0.013        2018           7          10  Benefits are cost savings.
     year.
                                             0.010       0.008       0.013        2018           3          10  Benefits are cost savings.
                                       ------------------------------------------------------------------------
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              0           0           0        2018           7          10
     year.
                                                 0           0           0        2018           3          10
                                       ------------------------------------------------------------------------
[[Page 68832]]

    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       ------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       ------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       ------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: No significant effect...............................................................................................................
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
    In line with Executive Order 13771, in table 2 we discuss
annualized and present values of costs and cost savings over an
infinite time horizon. The present value of the net costs would be $0
at both 3 and 7 percent discount rate. The total annualized cost
savings would range from $0.008 million to $0.013 million at both 3 and
7 percent discount rates.
                                                      Table 2--Executive Order 13771 Summary Table
                                               [in $ Millions 2016 Dollars, Over an Infinite Time Horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Primary          Lower           Upper          Primary          Lower           Upper
                          Item                            estimate  (7%)  estimate  (7%)  estimate  (7%)  estimate  (3%)  estimate  (3%)  estimate  (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................              $0              $0              $0              $0              $0              $0
Present Value of Cost Savings...........................           0.143           0.114           0.186           0.333           0.267           0.433
Present Value of Net Costs..............................         (0.143)         (0.114)         (0.186)         (0.333)         (0.267)         (0.433)
Annualized Costs........................................               0               0               0               0               0               0
Annualized Cost Savings.................................           0.010           0.008           0.013           0.010           0.008           0.013
Annualized Net Costs....................................         (0.010)         (0.008)         (0.013)         (0.010)         (0.008)         (0.013)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Net costs are calculated as costs minus cost savings. Values in parentheses denote net negative costs (i.e. cost-savings).
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
VII. Paperwork Reduction Act of 1995
    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
VIII. Federalism
    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule 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 proposed rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.
IX. Consultation and Coordination With Indian Tribal Governments
    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
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.
X. Reference
    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.
[[Page 68833]]
1. FDA/Economics Staff, ``Revised Procedures for the Announcement of
Approvals and Denials of Premarket Approval Applications and
Humanitarian Device Exemption Applications, Preliminary Regulatory
Impact Analysis, Preliminary Regulatory Flexibility Analysis,
Unfunded Mandates Reform Act Analysis,'' 2019 (available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).
List of Subjects in 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
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 814 be amended as follows:
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
1. The authority citation for part 814 continues to read as follows:
    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 381.
Sec.  814.40  [Amended]
0
2. In Sec.  814.40, remove ``515(d)(3)'' and add in its place
``515(d)(4)''
Sec.  814.44  [Amended]
0
3. Amend Sec.  814.44 as follows:
0
a. In the fourth sentence in paragraph (d)(1), remove ``515(d)(3)'' and
add in its place ``515(d)(4)'' and remove the sixth sentence;
0
b. In paragraph (d)(2), remove ``Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852'' and add in its place ``Freedom of Information
Staff's address listed on the Agency's website at https://www.fda.gov.''; and
0
c. In paragraphs (e)(2)(ii) and (f)(2), remove ``515(d)(3)'' and add in
its place ``515(d)(4)''.
Sec.  814.45  [Amended]
0
4. Amend Sec.  814.45 as follows:
0
a. In paragraph (d)(1), remove the third sentence and
0
b. In paragraph (e)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
0
5. In Sec.  814.116 revise the fourth sentence in paragraph (b) to read
as follows:
[thinsp]Sec.  814.116  Procedures for review of an HDE.
    (b) * * * The notice of approval of an HDE will be placed on the
FDA's home page on the internet (https://www.fda.gov) in accordance
with the rules and policies applicable to PMAs submitted under Sec.
814.20. * * *
Sec.  814.118  [Amended]
0
6. In Sec.  814.118(c)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
    Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27045 Filed 12-16-19; 8:45 am]
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