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2020-05-15
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Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability
Notices
D09002ee1bdb57fc4
D09002ee1bdb5803f
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.'' On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of SARS-CoV-2 testing. This guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020. The guidance describes four policies intended to help facilitate the development and use of SARS-CoV-2 tests during the public health emergency: Two policies for accelerating the development of certain laboratory tests for COVID-19--one leading to an Emergency Use Authorization (EUA) submission to FDA and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the laboratory resides and the State takes responsibility for COVID-19 testing by laboratories in its State; a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostics to laboratories for specimen testing after validation while an EUA submission is being prepared for submission to FDA; and a policy regarding the use of serological testing. In addition, FDA has included a reference to the availability, on FDA's website, of templates for commercial manufacturers and laboratories intended to facilitate EUA submissions for molecular, antigen, and serology tests. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
85 FR 29461
https://www.govinfo.gov/app/details/FR-2020-05-15/2020-10492
2020-10492
fr15my20-75
4164-01-P
Docket No. FDA-2020-D-0987
https://www.govinfo.gov/app/details/FR-2020-05-15/2020-10492
https://www.govinfo.gov/content/pkg/FR-2020-05-15/html/2020-10492.htm
https://www.govinfo.gov/content/pkg/FR-2020-05-15/pdf/2020-10492.pdf
3 p.
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85 FR 29461
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-10492
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2020-D-0987
4164-01-P
2020-10492
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.'' On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of SARS-CoV-2 testing. This guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020. The guidance describes four policies intended to help facilitate the development and use of SARS-CoV-2 tests during the public health emergency: Two policies for accelerating the development of certain laboratory tests for COVID-19--one leading to an Emergency Use Authorization (EUA) submission to FDA and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the laboratory resides and the State takes responsibility for COVID-19 testing by laboratories in its State; a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostics to laboratories for specimen testing after validation while an EUA submission is being prepared for submission to FDA; and a policy regarding the use of serological testing. In addition, FDA has included a reference to the availability, on FDA's website, of templates for commercial manufacturers and laboratories intended to facilitate EUA submissions for molecular, antigen, and serology tests. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
The announcement of the guidance is published in the Federal Register on May 15, 2020.
Brittany Schuck, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3556, Silver Spring, MD 20993-0002, 301- 796-5199.
CDRH-Guidance@fda.hhs.gov
https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders
https://www.fda.gov/media/135010/download
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
https://www.regulations.gov
Federal Register
Vol. 85, no. 95
Office of the Federal Register, National Archives and Records Administration
2020-05-15
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Table of Contents:
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