Policy for coronavirus disease-2019 tests during the public health emergency (revised): guidance for developers and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, November 15, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- COVID-19 Serological Testing -- standards COVID-19 Testing -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide FDA’s enforcement policies 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 this rapidly spreading, severe illness. This document supersedes “Policy for Coronavirus Disease2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff” issued May 11, 2020. The policies in this guidance are intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act). FDA continues to assess the evolving situation and intends to update this guidance as appropriate.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (20 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918351275606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351275606676