On January 31, 2024, FDA issued a press release that it planned to reclassify - to downclassify - "most high risk IVDs." Here. The new director for diagnostic tests (OIVD), Courtney Lias PhD, reiterated this last week at the annual "NextGenDx" conference in Washington.
This would have a huge impact on how implements its plan to regular lab-developed tests, but it would also greatly change the landscape for Class II, or moderate-risk, tests in general. It could tilt the economics and the landscape further towards kitted tests rather than RUOs and LDTs.
If you have a subscription to Genomeweb/360Dx, there's an excellent deep dive report on the topic published August 22 by Kelsy Ketchum. Find the article here (subscription).
Expert insights came from Christine Bump and Kate Simon.
Why Not Faster?
FDA plans to do this over a period of years, but I think it would be a dramatic improvement to move a lot faster. CMS makes hundreds - even thousands - of pages of rulemaking and policy making each year in 4-month cycles (such as start July 1, finish November 1). It's never been clear to me why FDA senior staff say, "We could do that, but it would take notice and comment rulemaking, and that requires five years."
A Few Tidbits
Just a quick peek at a couple highlights.
* Reclassification could streamline CDx approvals, but validation may still be complex. (I can see this for new gene-drug pairs, or if a particular is especially complex, not just a known mutation.)
* The shift from PMA to 510(k) may leave behind policy levers like modular submissions.
* Smaller players may be able to produce Class II kits whereas PMA kits were too costly and slow.
* Look for big impacts on the promised LDT regulatory scheme.
