Clinical Labs Find Fault In FDA Dx Reform Ideas, But Kit-Makers Signal General Approval
The American Clinical Laboratory Association (ACLA) split with other stakeholder groups in criticizing US FDA’s proposals for a new diagnostics regulatory regime. ACLA asked Congress to stay closer to Reps. Diana DeGette's and Larry Bucshon’s original Diagnostics Accuracy and Innovation Act draft bill language.
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A revised bill is circulating in both the US House and Senate to revamp FDA regulation of diagnostics. It would allow the agency to leverage a pre-certification process to validate test developers and includes other updates that are likely to appeal to the lab sector. But user fees and other elements could still be contentious.
The agency has responded to a draft diagnostics reform bill in Congress with proposed reforms that diverge some ways from the proposed legislation, but stick with the underlying goal of completely remaking how lab tests, including test kits and lab-developed tests, are regulated. The agency has put forward a proposal to establish a pre-certification process for test developers, divide most tests into high- or low-risk categories (but exempt many from pre-market review) and remove the concept of substantial equivalence.
The clinical lab industry and IVD test-kit-makers appear ready to work with lawmakers on diagnostic reforms that would create a new category of regulated product for all lab tests that would undergo a mix of US FDA and CMS oversight. Meanwhile, key groups representing laboratory professionals remain fundamentally opposed to the concept.