On Monday, April 29, 2024, the FDA released the final rule for its regulation of LDTs. The rule had been released in proposed form for public comment last fall.
FDA continues to plan an enforcement deadline of 3.5 years from now for high risk LDTs and 4 years from now for moderate risk LDTs. However, as FDA had proposed, submitting a PMA (or 510k and de novo) application will "stay the clock" for the duration of its review.
In thinking about 510K's and PMA's, remember #1 the FDA has promised to downclassify many PMA tests to 510k and #2 has early plans to completely revamp and speed the 510K process. Consider also wider use of predetermined change plans.FDA reserves the right to march in faster on "problematic" tests (the word problematic appears 46 times in the final rule, 6 in the draft rule).
FDA creates several new flexibilities for itself:
- NYS CLEP: Rule does not generally apply to NYS CLEP approved tests;
- The term CLEP appears 145 times in the final rule, 1 time in the proposed rule.
- See ChatGPT Sidebar here.
- WITHIN SYSTEM: Generally not applying to LDTs "by a laboratory within a healthcare system to meet an unmet need of patients receiving care in the same healthcare system."
- (This is similar to a pathway in the new European IVDR system).
- The term "same healthcare system" occurs 42 times in the final rule, 0 times in the proposed rule.
- See ChatGPT Sidebar here.
- GRANDFATHER: Generally enforcement discretion for LDTs marketed prior to the rule, and not altered.
- VA-DOD: Rule does not apply to V.A. or DOD;
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| click to enlarge (shows fall table 35, spring table 40, regulatory impact document) |
Benefits are still calculated in value per statistical life year (VSLY) (new regulatory impact, page 68ff). That is, costs continue to be real costs like professional labor and benefits continue to be projected life-years added or projected deaths delayed by IVDs.
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Regulatory Change Tiny; Satellite Rules All FDA Discretion
Most of the important stuff is still "FDA discretion," the actual rule change is only a few words long. Everything else (like pivotal proposals like grandfathering) relates to FDA internal plans and/or FDA discretion as time goes by. (E.g. FDA remarks on its ability to change the rules by guidance, p 42.)
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WHERE TO FIND IT
See the FDA webpage for the rule's release here:
See the Fed Reg location for the final rule here. The typeset rule will appear May 6.
See the typescript or pre-publication version of the actual final rule here--528 pages.
https://public-inspection.federalregister.gov/2024-08935.pdf
See the webpage for regulatory impact analysis here:
See the 178-page final impact analysis here:
https://www.fda.gov/media/178133/download?attachment
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See a new guidance document for "public health response" issues absent an actual declared emergency:
See a new guidance document for declared public health emergencies:
The final rule mentions CLEP 145 times, vs. just once or twice in the proposal. In my white paper on the proposed rule, I suggested that we should just require CLEP-like reviews - not 510(k) reviews by NYS CLEP, but the CLEP review itself. ("I think the [FDA"s] accuracy concern could be met by less drastic measures, such as having something roughly the equivalent of New York State review of LDTs.")
FDA notes (FN29) that certain tests exempted from NYS CLEP review are NOT exempted from this FDA rule.
