FDA proposes enforcing requirements for laboratory developed tests

The Food and Drug Administration Sept. 29 released a proposed rule that would phase out over four years its general enforcement discretion approach for most laboratory developed tests, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved in vitro diagnostic products. The proposed rule would amend FDA regulations to make explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer is a laboratory. Once the policy was fully phased in, the agency would require all IVD makers to meet the same applicable requirements, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments can be leveraged. 
 
The rule also seeks comments on alternative enforcement approaches for some IVDs offered as LDTs, including a different approach for academic medical center laboratories; the continuation of the current general enforcement discretion approach with respect to premarket review and quality system requirements for some or all currently marketed LDTs; and a phase-out period tailored for small laboratories.
 
FDA will accept comments on the proposed rule for 60 days after its publication in the Oct. 3 Federal Register.