This joint statement notes the evolution of Laboratory Developed Tests (LDTs) from the initial rule and approach the FDA had for oversite, and today's environment with the extensive use of LDTs in medical decisions. Last October, the FDA issued a proposed rule change that would go from the historic practice of not enforcing all aspects of the LDT regulations and moving to enforcing the existing regulations.
The CMS portion of the announcement addresses it's role in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) is separate and distinct from the FDA's role in the reviews of the analytical and clinical validity of LDTs.
This Link takes you to the announcement.
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