Document ID: FDA-2019-N-3101-0006
Agency: fda
Document Type: Rule
Title: Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
Posted Date: 2022-01-13T05:00Z

[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2042-2045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00501]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2019-N-3101]
RIN 0910-AI10

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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule 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). This final rule discontinues the 
publication in the Federal Register after each quarter of 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 taking 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 updating Agency contact information and 
statutory references in certain sections of the PMA and HDE regulations 
for purposes of accuracy, clarity, and consistency.

DATES: This rule is effective February 14, 2022.

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, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: 
    For information concerning the final rule as it relates to devices 
regulated by the Center for Biologics Evaluation and Research: Tami 
Belouin, 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 final 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. 2438, Silver 
Spring, MD 20993-0002, 301-796-6524.

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. Background
    A. Need for the Regulation
    B. History of the Rulemaking
    C. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Specific Comments and FDA Response
    C. Comments Outside the Scope of This Rulemaking
V. 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. Reference

I. Executive Summary

A. Purpose of the Final Rule

    FDA is amending 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 taking 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 updating Agency contact information and 
statutory references in certain PMA and HDE regulations for purposes of 
accuracy, clarity, and consistency.

B. Summary of the Major Provisions of the Final Rule

    FDA is amending its regulations regarding the announcement 
procedures for the approval and denial of PMAs and HDEs. FDA is 
discontinuing 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 final 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 final rule is that it will 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 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. We estimate that this final rule will result in no additional 
costs to industry because the

[[Page 2043]]

rule will not require performance of any additional tasks and, 
therefore, will not impose any additional regulatory burden on the 
industry.

II. Background

A. Need for the Regulation

    FDA is amending 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 taking 
this action to improve the efficiency of announcing approvals and 
denials of PMAs and HDEs and eliminate duplication in announcing this 
information. The final rule allows FDA staff to focus on other Agency 
priorities and utilize FDA staff resources more efficiently. FDA is 
also revising 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 updating 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 making available on 
the internet and placing on public display SSED, 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.
    In the Federal Register of December 17, 2019 (84 FR 68829), FDA 
published a proposed rule entitled ``Revised Procedures for the 
Announcement of Approvals and Denials of Premarket Approval 
Applications and Humanitarian Device Exemption Applications'' to 
discontinue publishing in the Federal Register after each quarter a 
list of PMA and HDE approvals and denials announced in that quarter. We 
also proposed to update Agency contact information and statutory 
references in certain sections of the PMA and HDE regulations for 
purposes of accuracy, clarity, and consistency. After consideration of 
the comments received, we are now finalizing the proposed rule without 
change.

C. Summary of Comments to the Proposed Rule

    We received comments on the proposed rule from individual 
submitters. We received one comment in support of the proposed rule and 
one comment against discontinuing the quarterly publication in the 
Federal Register of a list of approvals and denials of PMAs and HDEs. 
These comments are further summarized in section IV.

III. Legal Authority

    We are issuing this final 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. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received comments on the proposed rule from individual 
submitters. We describe and respond to the comments in sections IV.B 
and C of this document. We have numbered each comment to help 
distinguish between different comments. 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. Specific Comments and FDA Response

    (Comment 1) One comment supported the proposed rule.
    (Response 1) We acknowledge and appreciate the supportive comment.
    (Comment 2) One comment opposed discontinuing the publication in 
the Federal Register after each quarter of a list of PMA and HDE 
approvals and denials announced in that quarter. The comment stated 
that the Federal Register provides a complete, archivable, and 
reviewable record of Federal Agency decisions, that the FDA website 
does not provide. The comment further noted that the quarterly Federal 
Register summary may be useful to persons searching for aggregate 
trends in FDA actions.
    (Response 2) We do not believe the quarterly Federal Register 
notice is needed to provide an adequate record of PMA and HDE approvals 
and denials. The Federal Register notice merely summarizes the 
quarterly PMA and HDE approvals and denials; it does not provide 
information on those approvals and denials beyond what can be obtained 
in other formats on the FDA website. Additionally, we will continue to 
give the public notice of PMA and HDE approvals and denials by placing 
notices of approvals and denials on FDA's home page on the internet. 
These notices, along with certain supporting documentation, are also 
maintained and can be viewed online at https://www.regulations.gov.
    Furthermore, we do not believe it is necessary to publish the 
quarterly Federal Register notices as a search tool for ``aggregate 
trends in FDA actions.'' We note that there are existing tools such as 
FDA's searchable PMA database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm) and HDE database (https://

[[Page 2044]]

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm; https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/premarket-approvals-and-humanitarian-device-exemptions-supporting-documents) that 
the public can utilize to search for information on PMA and HDE 
approvals over a certain period of time.

C. Comment Outside the Scope of This Rulemaking

    (Comment 3) One comment questioned which products FDA evaluates 
before they are sold.
    (Response 3) We decline to respond because this comment is outside 
the scope of this final rule.

V. Effective Date

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

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
believe that this final 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 final rule will not impose any additional 
regulatory burden on the industry, we certify that the 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 issuing ``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 $158 
million, using the most current (2020) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    The benefit of this final rule is that it will result in cost 
savings to FDA from discontinuing publishing in the Federal Register, 
on a quarterly basis, a list of approvals and denials of PMAs and HDEs. 
Discontinuing publishing Federal Register notices with these approval 
and denial lists will eliminate duplication in announcing this 
information; information on these approvals and denials will continue 
being readily available to the public on FDA's home page on the 
internet (https://www.fda.gov).
    We estimate that this final rule will result in no additional costs 
to industry because the rule will not require performance of any 
additional tasks. The rule, therefore, will not impose any additional 
regulatory burden on the industry.
    Table 1 summarizes the estimated benefits and costs of the final 
rule. Annualized over 10 years, the estimated benefits (i.e., cost 
savings) of the final rule 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 final rule ranges 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 final rule 
are $0 at both 3 and 7 percent discount rate. The present value of 
costs of the final rule is also $0 at both 3 and 7 percent discount 
rate.

                                      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/         $0.010      $0.008      $0.013        2020           7          10  Benefits are cost savings.
     year.
                                             0.010       0.008       0.013        2020           3          10  Benefits are cost savings.
    Annualized Quantified.
    Qualitative.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              0           0           0        2020           7          10
     year.
                                                 0           0           0        2020           3          10
    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.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 2045]]

    We have developed a comprehensive 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. 1) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact

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

VIII. Paperwork Reduction Act of 1995

    This final 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.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 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 Executive Order and, consequently, a federalism summary impact 
statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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 Executive Order and, consequently, a 
tribal summary impact statement is not required.

XI. 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.

1. FDA/Economics Staff, ``Revised Procedures for the Announcement of 
Approvals and Denials of Premarket Approval Applications and 
Humanitarian Device Exemption Applications, Regulatory Impact 
Analysis, Regulatory Flexibility Analysis, Unfunded Mandates Reform 
Act Analysis,'' 2020 (available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations).

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, 21 CFR 
part 814 is 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, 379k-1, 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:

 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: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00501 Filed 1-12-22; 8:45 am]
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