FDA repeatedly adapted emergency use authorization policies to address the need for COVID-19 testing
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Report in brief (United States. Department of Health and Human Services. Office of Inspector General)
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- COVID-19 Testing Device Approval Government Regulation United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Review. At the start of the COVID-19 pandemic, no test existed to identify this novel virus. Testing is vital to diagnose infected individuals and understand spread during infectious disease emergencies. The Food and Drug Administration (FDA) used its Emergency Use Authorization (EUA) authority to facilitate the development and availability of COVID-19 tests. Members of Congress have expressed strong interest in the availability and effectiveness of both diagnostic and serology tests. This review assesses how FDA used its EUA authority to authorize COVID-19 tests during the crucial first months of the pandemic. How OIG Did This Review. We focused our review on the early months of the pandemic: January 1 through May 31, 2020. We relied on FDA documents, data, and interviews to determine how FDA conducted EUA activities and decision-making. We surveyed and received responses from 237 test developers that engaged with FDA about their COVID-19 tests and analyzed survey responses to assess experiences working with FDA. We also interviewed test developers and representatives from a professional laboratory association for context about developer experiences.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (46 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918715886506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918715886506676