Policy for monkeypox tests to address the public health emergency: guidance for laboratories, commercial manufacturers, and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- 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, September 7, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Monkeypox -- diagnosis Monkeypox -- prevention & control Public Health Reagent Kits, Diagnostic United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the recent monkeypox outbreak. On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined1 under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that there is a public health emergency, or significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On September 7, 2022, the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of monkeypox virus. Rapid detection of monkeypox cases in the United States requires wide availability of diagnostic testing to help control the spread of this contagious infection. This guidance describes FDA’s review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, describes FDA’s enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity, 3provides recommendations for diagnostic test validation, describes FDA’s enforcement policies for FDA-cleared or authorized monkeypox diagnostic tests that are modified, and describes FDA’s enforcement policies for certain serology tests. In light of the public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being issued without prior public comment, but it remains subject to comment in accordance with the Agency’s good guidance practices. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (12 pages))
- NLM Unique ID:
- 9918486675606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486675606676