> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Mulls Covid-19 Serology Test Policy Change
- URL: https://www.fdaweb.com/fda-mulls-covid-19-serology-test-policy-change/
- Published: 2020-04-27T12:00:00.000Z
- Updated: 2026-09-14T16:12:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146657

FDA told a Congressional briefing earlier this month that it is considering tougher requirements on Covid-10 serology (antibody) tests that are currently coming on the market without normal vetting or review under the agency’s emergency use authorization (EUA) pathway. The 4/17 briefing before House Oversight Committee staff by CDRH director **Jeff Shuren** and other HHS officials indicated that FDA has not been able to assess the reliability of any serological antibody test on the market. Shuren told the briefing that the agency will “go back and revisit” its policy change “after receiving some of these validation results and may consider requiring EUA submissions for all serology tests,” according to a [committee report](https://oversight.house.gov/sites/democrats.oversight.house.gov/files/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf?ref=fdaweb.com).

Currently, almost 200 serology tests are on the market and only eight have emergency use authorizations and the rest have not been authorized. The agency recently [updated its Web site](https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?ref=fdaweb.com) to better clarify which tests have been authorized by FDA and which have not.

Based on a lack of testing during the pandemic, FDA relaxed its policies in March to allow serology tests to enter the market with virtually no vetting. Reliability concerns and questionable marketing have followed, and FDA now finds itself with a large problem to address ([see earlier story](https://www.fdaweb.com/fda-likely-regretting-unapproved-antibody-test-policy/)). The [policy](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency?ref=fdaweb.com) change tried to explain that the agency would not object when developers of serological tests market or use their tests without prior FDA review where: (**1**) the tests are validated by the developer to determine that they are accurate and reliable, (**2**) notification of the developer’s validation is provided to FDA, and (**3**) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis.

FDA says it is collaborating with the National Institutes of Health’s National Cancer Institute, National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention to “establish a capability at NIH to evaluate serological tests for developers. This effort includes tests already available for use, as well as tests not yet on the market where additional validation data is needed to support an EUA.” During the 4/17 briefing, HHS explained that this program is voluntary, and any manufacturer can submit copies of its test kit to be validated by the group. HHS is not requiring manufacturers to submit tests, and it has no plans to attempt to validate tests that it does not receive on a voluntary basis. Two weeks into the program, HHS stated that it had not yet validated any test, according to the committee report. HHS also stated that it expects preliminary results by the end of April.

The committee report was also very critical of FDA enforcement for not taking appropriate actions to “rid the market of fraudulent tests that falsely claim to be FDA-approved, are illegally marketed for at-home use, or falsely claim to be effective. During the 4/17 briefing, FDA said it has ‘not taken enforcement action yet.’ Though FDA was able to correct some fraudulent marketing practices informally by emailing the companies, it has not sent any formal Warning Letters or taken any other public action against any company offering diagnostic tests or testing services.”