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# OIG Identifies FDA Emergency Use Authorization Issues
- URL: https://www.fdaweb.com/oig-identifies-fda-emergency-use-authorization-issues/
- Published: 2022-09-21T12:00:00.000Z
- Updated: 2026-09-14T18:00:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152785

The HHS Office of Inspector General (OIG) says there are lessons to be learned from the way FDA approached Emergency Use Authorization (EUA) policies for Covid-19 testing. The OIG says that to develop its [report](https://oig.hhs.gov/oei/reports/OEI-01-20-00380.asp?ref=fdaweb.com), it relied on FDA documents, data, and interviews to determine how the agency conducted EUA activities and decision-making. It also surveyed and received responses from 237 test developers that engaged with FDA about their tests and analyzed survey responses to assess experiences working with the agency. Finally, it interviewed test developers and representatives from a professional laboratory association for context about developer experiences.

“Our findings underscore the need to apply actionable insights from FDA’s early experiences with the Covid-19 pandemic toward current and future infectious disease emergencies to better balance test availability and quality,” the report says. The report makes six recommendations and says FDA concurred with all of them:

- assess and, as appropriate, revise guidance for test EUA submissions;
- develop a suite of EUA templates for future emergencies involving novel pathogens;
- expand CDRH’s existing device-tracking platform to facilitate EUA submission and monitoring;
- expand and improve resources for test developers on the EUA process;
- establish formal communication channels between FDA and the laboratory community, to be used in emergencies that require testing; and
- work with federal partners to implement lessons learned about a national testing strategy that goes beyond the EUA process.