Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the COVID-19 public health emergency (revised): guidance for industry and Food and Drug Administration staff
United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
United States. Food and Drug Administration. Office of Strategic Partnerships and Technology Innovation. issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
[Silver Spring, MD] : Center for Devices and Radiological Health, November 2020
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 implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356j), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency.
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