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# Cassidy Wants Test Regulation Ideas
- URL: https://www.fdaweb.com/cassidy-wants-test-regulation-ideas/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156562

Sen. **Bill Cassidy** (R-LA), who says FDA is exceeding its legislative authority in seeking to reform clinical test regulation through rulemaking, is asking stakeholders for their ideas on how Congress can modernize current regulations to support innovation and ensure the tests are safe and effective to use. In an open [letter](https://www.help.senate.gov/ranking/newsroom/press/ranking-member-cassidy-seeks-information-from-stakeholders-on-regulation-of-clinical-tests?ref=fdaweb.com), Cassidy says past congressional efforts to reform the regulation of diagnostics have been unsuccessful, resulting in missed opportunities to implement substantive updates to the regulatory frameworks for laboratory services and diagnostic products.

He asks “interested parties” to respond by 4/3 to 21 questions on the FDA regulatory framework for diagnostics and the 1988 Clinical Laboratory Improvement Amendments regulatory framework for laboratory-developed tests.

“Clinical tests are essential healthcare resources, informing 70% of all clinical decisions through diagnosis, screening, staging, and managing of diseases and medical conditions,” Cassidy writes. “Since 1976, there have been no significant reforms to the regulation of clinical tests, even as new, innovative tests are being used in healthcare settings.”