[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34691-34692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1138]


Effects of the COVID-19 Public Health Emergency on Formal 
Meetings and User Fee Applications for Medical Devices--Questions and 
Answers (Revised); Withdrawal of Guidance

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the withdrawal of the guidance document entitled ``Effects of the 
COVID-19 Public Health Emergency on Formal Meetings and User Fee 
Applications for Medical Devices--Questions and Answers (Revised),'' 
which was issued in June 2020 (and updated December 2020). FDA is 
withdrawing this guidance document in recognition that the conditions 
that created the need for these policies have evolved, such that these 
policies are no longer needed.

DATES: The withdrawal date is July 7, 2022.

FOR FURTHER INFORMATION CONTACT: 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, 301-796-5640, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support 
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in June 2020, the Agency published this guidance 
document (June 23, 2020 at 85 FR 34638) and updated it in December 
2020, to recognize that the COVID-19 public health emergency was 
affecting the public health in numerous direct and indirect ways, 
including device development programs.\2\ This guidance document 
answered frequently asked questions and implemented temporary policies 
to reduce industry burden.
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    \1\ The virus has been named ``SARS-CoV-2'' and the disease it 
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
    \2\ The term ``device(s)'' in this document refers to devices 
regulated by the Center for Devices and Radiological Health (CDRH) 
as well as devices regulated by the Center for Biologics Evaluation 
and Research (CBER), including devices regulated as biological 
products under section 351 of the Public Health Service (PHS) Act.
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    FDA has continually assessed the needs and circumstances related to 
these temporary policies, and as relevant needs and circumstances 
evolved, the Agency made updates and modifications to these temporary 
policies. FDA has determined that the needs and circumstances related 
to the temporary policies described in the guidance document have 
evolved, such that they are no longer needed, and the guidance document 
should be withdrawn. In weighing the current burden to industry and the 
Agency relating to the COVID-19 response efforts with the need to 
ensure patients have timely access to new devices, FDA is withdrawing 
this guidance document. Below is a brief description of the guidance 
document and temporary policies that will be withdrawn:
    The guidance articulated FDA's policy that for marketing 
submissions and applications on hold, FDA did not intend to consider a 
submission or application to be withdrawn for an additional 180 days 
beyond the relevant response date. Returning to pre-pandemic policies 
for marketing submissions and applications placed on hold after the 
withdrawal of this guidance means FDA will generally consider the 
submission or application to be withdrawn if the submitter or applicant 
does not provide a complete response to major deficiency letters for 
Premarket Approval Applications (PMAs) (original and supplements) \3\ 
and Humanitarian Device Exemption (HDE) applications (original and 
supplements) \4\ within 360 days or to additional information letters 
for 510(k) \5\ and De Novo requests \6\ within

[[Page 34692]]

180 days, consistent with preexisting guidance.
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    \3\ For more information, please see the FDA guidance document 
entitled ``FDA and Industry Actions on Premarket Approval 
Applications (PMAs): Effect on FDA Review Clock and Goals'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals).
    \4\ For more information, please see the FDA guidance document 
entitled ``Humanitarian Device Exemption (HDE) Program'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/humanitarian-device-exemption-hde-program).
    \5\ For more information, please see the FDA guidance document 
entitled ``FDA and Industry Actions on Premarket Notification 
(510(k)) Submissions: Effect on FDA Review Clock and Goals'' 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-and-goals).
    \6\ For more information, please see the FDA guidance document 
entitled ``FDA and Industry Actions on De Novo Classification 
Requests: Effect on FDA Review Clock and Goals'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals).
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    When the COVID-19 public health emergency began, FDA understood 
that applicants may face challenges affecting their ability to meet 
their applicable response date for submissions placed on hold. FDA also 
recognized our potential difficulty in processing a high volume of 
individual extension requests on a timely basis. To alleviate these 
concerns, the guidance document articulated that FDA did not intend to 
consider an application or submission to be withdrawn for an additional 
180 days beyond the relevant response date, regardless of whether the 
applicant submitted an extension request.
    By weighing the current burdens on industry with FDA's interest in 
patients receiving timely access to new devices, FDA has determined it 
is in the interest of the public health to return to pre-pandemic 
policies regarding hold times. Reverting to policies regarding hold 
times described in the preexisting guidance documents should facilitate 
more timely premarket review of innovative and potentially lifesaving 
devices. In addition, closing out files that have been abandoned in a 
timelier manner allows for better management of the device review 
program. The Agency acknowledges that the circumstances giving rise to 
the public health emergency declaration for the COVID-19 pandemic 
continue to exist. However, the conditions that created the need for 
these policies have evolved, such that these policies are no longer 
needed, and it is in the best interest of patients and providers to 
reinstitute the original hold times to ensure patients have timely 
access to advanced technologies, diagnostics, and therapeutics without 
unnecessary delay.
    The guidance document also discussed FDA's ability to host advisory 
committee meetings virtually and FDA's intention to work with relevant 
stakeholders to host all advisory committee meetings virtually. In 
returning to pre-pandemic policies, FDA will assess the appropriate 
venue for advisory committee meetings, keeping in mind FDA's successful 
implementation of virtual advisory committee meetings. Consistent with 
existing policy, the venue will be announced via the Federal Register.
    Therefore, after careful review of current Agency processes, 
industry practices with regard to resolving submission deficiencies, 
and comments submitted to the public docket associated with the 
guidance, FDA is withdrawing the ``Effects of the COVID-19 Public 
Health Emergency on Formal Meetings and User Fee Applications for 
Medical Devices--Questions and Answers (Revised)'' guidance in its 
entirety.

II. Withdrawal Date

    The withdrawal date for the guidance document discussed in this 
document is July 7, 2022. For submissions or applications that receive 
a major deficiency letter for PMA and HDE applications or additional 
information letters for 510(k) and De Novo requests prior to or on the 
guidance withdrawal date, FDA does not intend to consider the 
submission or application to be withdrawn for an additional 180 days 
beyond the relevant response date. For submissions or applications that 
receive a major deficiency letter or additional information letter 
after the guidance withdrawal date, FDA will generally consider the 
application or submission to be withdrawn if a complete response is not 
received by the relevant response date identified in that letter.
    Authority: 21 U.S.C. 371(h).

    Dated: June 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12176 Filed 6-3-22; 8:45 am]
BILLING CODE 4164-01-P


