2022-20828. Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) entitled “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised).” FDA is issuing this guidance to provide FDA's revised enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection. This document supersedes “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised)” issued November 15, 2021. The guidance identified in this notice addresses issues related to the COVID-19 PHE and has been issued in accordance with the expedited process FDA announced in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

DATES:

The announcement of the guidance is published in the Federal Register on September 28, 2022.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

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-2020-D-0987 for “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised).” Received comments 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, 240-402-7500.

• 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, 240-402-7500.

You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))).

Submit written requests for a single hard copy of the guidance document entitled “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised)” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Toby Lowe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a final guidance entitled “Policy for Coronavirus Disease—2019 Tests During the Public Health Emergency (Revised),” which supersedes the guidance of the same title issued November 15, 2021. FDA is issuing this guidance to provide FDA's updated enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), the FDA Commissioner may authorize the use of unapproved medical products, or unapproved uses of approved medical products, in certain emergency circumstances, after the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear threat agents when certain criteria are met (emergency use authorization (EUA)). As of August 15, 2022, FDA has authorized under EUA more than 439 tests for COVID-19, including more than 354 diagnostic and 85 serology or other immune response tests. Further, two molecular diagnostic COVID-19 tests have been granted marketing authorization through the traditional device premarket review pathways.

In the context of a public health emergency involving pandemic infectious disease, it is critically important that tests are validated because false results not only can negatively impact the individual patient but also can have a broad public health impact. False positive results for diagnostic tests, for example, can lead to unnecessary quarantine and potential further spread when presumed positive individuals are quarantined together, wasted contact tracing and testing resources, and delay in accurate diagnosis and appropriate treatment for the individual. False negative results can lead to lack of appropriate treatment for the individual and further spread of the disease.

FDA has continued to closely monitor the COVID-19 testing landscape and believes it is appropriate to update its policies to reflect the current needs of the pandemic. As explained throughout this updated guidance, FDA intends to review the EUA requests for a smaller subset of tests. Traditional marketing pathways remain available to all developers and FDA encourages developers of tests that fall outside the scope of the priorities outlined in this updated guidance to pursue those routes. In sum, FDA has revised this guidance to update the types of COVID-19 tests for which the Agency intends to review EUA requests, to discuss the use of the traditional premarket review pathways for other types of COVID-19 tests for which the Agency does not intend to review EUA requests, and to make minor updates to the enforcement policies.

On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, the Secretary of Health and Human Services (HHS), pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d), determined that a PHE exists and has existed since January 27, 2020, nationwide.^[1] On March 13, 2020, there was a Presidential declaration that the COVID-19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.^[2]

In the Federal Register of March 25, 2020 (85 FR 16949) (the March 25, 2020, notice) (available at https://www.govinfo.gov/​content/​pkg/​FR-2020-03-25/​pdf/​2020-06222.pdf), FDA announced various procedures for making available FDA guidances related to the COVID-19 PHE. The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID-19 PHE and to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders, prior public participation would not be feasible or appropriate before FDA implemented COVID-19-related guidances. FDA will continue to issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and § 10.115(g)(2)). The guidances are available on FDA's web pages entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders” (available at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and “Search for FDA Guidance Documents” (available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents.) Although this guidance has been implemented immediately without prior comment, FDA will consider all comments received and revise the guidance as appropriate (see § 10.115(g)(3)).

This guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidance represents the current thinking of FDA. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (PRA). The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the table below. This guidance also contains a new collection of information not approved under a current collection. The new collection of information has been granted a public health emergency (PHE) waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/​public-health-emergency-declaration-pra-waivers.

21 CFR part or guidance	Topic	OMB control No.	New collection covered by PHE PRA waiver
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders	Emergency Use Authorization	0910-0595
“Administrative Procedures for CLIA Categorization; Guidance for Industry and Food and Drug Administration Staff” and “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff”	Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization	0910-0607
803	Medical devices; medical device reporting; manufacturer reporting, importer reporting, user facility reporting, distributor reporting	0910-0437
807, subpart E	Premarket notification	0910-0120
814, subparts A through E	Premarket approval	0910-0231
860, subpart D	De Novo classification process	0910-0844
“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”	Q-submissions; pre-submissions	0910-0756
			Voluntary templates to facilitate the preparation and submission of an Emergency Use Authorization request for various types of COVID-19 tests.

III. Electronic Access

Persons with access to the internet may obtain the guidance at:

• FDA web page entitled “Guidance Documents (Medical Devices and Radiation-Emitting Products)” available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products;

• FDA web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,” available at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-issues/​covid-19- related-guidance-documents-industry-fda-staff-and-other-stakeholders ;

• FDA web page entitled “Search for FDA Guidance Documents” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents; or

• https://www.regulations.gov.

Dated: September 21, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  Secretary of Health and Human Services, “Determination that a Public Health Emergency Exists” (originally issued on January 31, 2020, and subsequently renewed), available at: https://www.phe.gov/​emergency/​news/​healthactions/​phe/​Pages/​default.aspx.

2.  Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020), available at: https://trumpwhitehouse.archives.gov/​presidential-actions/​proclamation-declaring-national-emergency-concerning-novel-coronavirus- disease-covid-19-outbreak/ . On February 24, 2021, there was a Presidential Declaration continuing the national emergency concerning the COVID-19 pandemic beyond March 1, 2021. See Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at https://www.federalregister.gov/​documents/​2021/​02/​26/​2021-04173/​continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.