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# FDA Covid-19 Serology Tests Lessons Learned
- URL: https://www.fdaweb.com/fda-covid-19-serology-tests-lessons-learned/
- Published: 2021-02-16T12:00:00.000Z
- Updated: 2026-09-14T16:46:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148671

CDRH director **Jeffrey Shuren** and Office of In Vitro Diagnostics and Radiological Health director **Timothy Stenzel** say that knowing what they know now, they would not have permitted SARS-CoV-2 serology tests to be marketed without FDA review and authorization. [Writing](https://www.nejm.org/doi/full/10.1056/NEJMp2033687?ref=fdaweb.com) in a *New England Journal of Medicine* Perspective, Shuren and Stenzel list five lessons learned from the agency’s experience with Covid-19 serology tests that flooded the market after some government officials touted their use in reopening the economy and insurance coverage was provided for some uses not supported by science: 

- it is important to authorize medical products independently, based on sound science, and not permit market entry of tests without authorization;
- the federal government should coordinate the preparation of a public/private research plan to address epidemiologic questions about disease spread and immunity at the beginning of an outbreak as part of its preparedness plan;
- capacity should be established within or on behalf of the federal government to evaluate test performance before outbreaks occur so that independent evaluation can be performed quickly during an outbreak;
- the scientific and medical communities should understand the purpose and clinical use of serology tests and how to appropriately use test results in general to inform patient care; and
- all parties involved in public health emergency response need better information more quickly.