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# Reasons HHS Decision on Lab Tests Was Good: Attorney
- URL: https://www.fdaweb.com/reasons-hhs-decision-on-lab-tests-was-good-attorney/
- Published: 2020-09-01T12:00:00.000Z
- Updated: 2026-09-14T16:27:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147558

Attorney **Jeffrey Shapiro** (Hyman, Phelps & McNamara) identifies two reasons supporting the recent HHS announcement that FDA will no longer conduct premarket review of laboratory-developed tests (LDTs). Writing in his firm’s *FDA Law Blog*, Shapiro says the reasons are that: 

- clinical laboratories will no longer be under the threat that FDA may select their assays for regulation, which may have chilled innovation; and
- FDA can better direct its resources against Covid-19.

“The new HHS policy is an excellent step to more rationally apply FDA’s resources during the pandemic,” Shapiro writes. “In the bigger picture, it should take no less than an act of Congress to determine the proper scope of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Clinical Laboratories Improvement Act (CLIA) as applied to clinical laboratories. Congress may decide that CLIA preempts the FFDCA inside clinical laboratories. Or, Congress may decide that developments in testing technology and business models warrant an overlay of FDA regulation. If so, the new statute should supply the boundaries of such regulation and harmonize CLIA with the FFDCA.”

The article says an important issue not addressed in the HHS announcement is how to define LDTs that are no longer subject to FDA premarket review. Shapiro suggests that HHS “simply preclude FDA from the premarket review of any test offered by a clinical laboratory as that term is defined by CLIA. Such a facility-based approach would be grounded in an existing statute, he writes.

He cautions that if FDA continues to apply its longstanding definition of LDTs, it will still be able to review some of them, which is not what HHS wants. “It \[FDA\] will continue to pick and choose among LDTs offered by clinical laboratories, regulating some of them as ‘not true LDTs’ as determined by FDA based upon subjective criteria not grounded in law,” he says “A facility-based approach would more fully carry out the new HHS policy of precluding FDA from the premarket review of LDTs. At the same time, it would permit FDA to continue regulating traditional test kits manufactured outside clinical laboratories (and typically shipped to laboratories for use).”

Another concern, according to Shapiro, is that HHS has said that FDA will abstain only from premarket review, raising the question of whether the agency could still apply Quality System Regulation, Medical Device Reporting, and labeling requirements. He says it would be illogical and potentially outside the law for HHS to allow FDA to do so.