College of American Pathologists publishes a newsletter about advocacy issues, which is open-access. Here, they asked FDA a question about LDTs that appear after the issuance date of the rule (after May 2024).
The CAP question is,
There is confusion about the regulatory obligations for LDTs developed after the issuance dates. We have received many questions about how to classify the tests, what documentation is needed, and can laboratories bring these systems online now.
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FDA gives the CAP a completely boilerplate (pro forma) answer about general device classificatioin - PMA, 510k, etc.
The FDA didn't even answer what I took to be the main point of the question [issuance date]. In general, LDTs before June 2024 must comply with paperwork rules in 2025, 2026, but no PMA/510k. LDTs launched after June 2024 must comply with those paperwork rules PLUS PMA/510k.
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Here's the interesting answer, for me. Tests around before May 2024 are "grandfathered" except for various requirements in May 2025, May 2026, and May 2027. Then come the deadlines for actual PMA/510k filing. If those documents are filed, FDA will allow tests to remain on the market until the documents are reviewed (anticipated a backlog approaching infinity). That's filing PMA by November 2027, or 510k by May 2018.
Here's what's interesting. If your PMA or 510k is filed later, like June 2018, you can't stay on the market (since you don't have on-file PMA or 510k by the staged deadlines), and, your PMA or 510k will be reviewed - god knows when, since it will be queued behind howeer many 10,000, or 50,000, PMAs or 510ks that the FDA lacks the staff to process. So an LDT with paperwork filed in, say, June 2018, would be allowed for use....ever? never? 2028?
