FDA Looks To Whittle Down Dx Review Load With Pre-Certs, Third-Party Assists
US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.
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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.
In a Dec. 6 blog post, US FDA officials continued pressing for a new system of diagnostics regulation that puts laboratory-developed test services (LDTs) on the same footing as IVD test kits, all under a new framework where only about 10% of tests would require pre-market review.
Under a new plan and draft guidance issued by US FDA, the agency is hoping to streamline and improve its third-party review program. The goal is to spend substantially less FDA resources re-reviewing low-to-moderate risk 510(k) applications that go through the program and allow products to enter market sooner.