'Reined-In' US Diagnostics Legislation Adds Pre-Certification, Other Updates
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.
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Covington & Burling partner Scott Danzis tells Medtech Insight why diagnostics developers and labs should keep an eye on the third iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act – reintroduced in the US Senate on 24 June – and why the bill has a better shot at becoming law this time.
The Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which calls for a new regulatory framework for diagnostic tests, has been reintroduced in the US Congress.
Rep. Frank Pallone Jr. calls HHS secretary Alex Azar on the carpet for hobbling the FDA’s oversight of laboratory developed tests.