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# FDA New Approach to Regulating In Vitro Tests
- URL: https://www.fdaweb.com/fda-new-approach-to-regulating-in-vitro-tests/
- Published: 2018-12-06T12:00:00.000Z
- Updated: 2026-09-15T00:49:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142981

FDA commissioner **Scott Gottlieb**, CDRH director **Jeffrey Shuren**, and Gottlieb chief of staff **Lauren Silvis** say there is a need for a unified approach to the regulation of *in vitro* clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that is helping find new treatments for disease. In an online [*FDA Voices on Policy*](https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm627742.htm?ref=fdaweb.com) the three write that the agency supports an approach that would: 

- focus agency review resources where they could make the most difference and where the risk is highest;
- provide strong postmarket authorities to protect patients from harm;
- require transparency about test performance and limitations;
- complement rather than duplicate laboratory certifications;
- incorporate third-party review and inspection; and
- include a pathway for earlier patient access to breakthrough technologies.

The post says FDA has shared its ideas with Congress, patient groups, providers, professional societies, and test developers.

Under the proposal, the agency review would focus on the analytical and clinical validity of the tests, as well as the unique issues that a test might present. “For about 40-50% of tests,” the three write, “we believe that a pre-certification type of program would be the right way to ensure analytical and clinical validity and protect patients from false or misleading test results, while promoting innovation. A pre-certification approach would allow FDA to evaluate a developer and its ability to design and validate a test. FDA could leverage this rigorous and targeted evaluation so that a review of each test itself would not be needed or could be streamlined. Other tests, including manual, low risk, custom, low volume, rare disease, forensic, and public health surveillance, could be exempt from pre-market review, if coupled with appropriate provisions to allow FDA to take action against any problematic tests in order to protect patients from harm.”