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# Groups Want Regulation of Lab-Developed Tests
- URL: https://www.fdaweb.com/groups-want-regulation-of-lab-developed-tests/
- Published: 2023-05-31T12:00:00.000Z
- Updated: 2026-09-14T18:35:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154576

The Center for Science in the Public Interest and 15 other public interest organizations are asking FDA to regulate laboratory-developed tests (LDTs). A 5/30 [letter](https://www.cspinet.org/sites/default/files/2023-05/CSPI%20FDA%20letter.pdf?ref=fdaweb.com) says the agency has the authority to regulate LDTs but has chosen not to use it because early tests were fairly simple and used on a small number of patients. “However, the availability and complexity of these tests have grown over time and many have been found to be inaccurate,” the letter says.

FDA issued a 2014 draft guidance outlining a risk-based approach to the premarket review of LDTs and a process for labs to notify the agency of such tests. Ultimately, however, the agency chose not to finalize the guidance to permit additional public discussion of an appropriate approach and to give Congress a chance to approve a legislative solution.

“Yet Congress has failed to provide such a solution,” the letter says. “Since the release of an FDA discussion paper, there has been significant public debate over LDT regulation, and the introduction of two bills that ultimately did not pass…. We applaud FDA’s past efforts to regulate LDTs and, if a strong bill does not progress to Congress, urge the agency to implement regulation for LDTs that includes requirements for analytical and clinical validation, quality control, adverse event reporting, and transparency. Such regulation would help close the gap created by the lack of adequate independent oversight and ensure that accurate LDTs are marketed to consumers and used to guide patient care, while also promoting innovation and competition in the diagnostic testing industry.”