A Hearing... but not a Listening

Monday, July 19, 2010

If you were following the FDA LDT meeting on Twitter, it was clear right away how difficult it was for some people to hear what FDA was trying to explain, namely:

  • No, these aren't new rules 

  • No, you aren't going to get to keep doing what you're doing

  • No, we don't owe you any commitments on specific rules or timelines 

It's simple, really. There are rules currently being flaunted. FDA has tolerated some of this willful rule-bending for some amount of time. That time is coming to an end. The rest is timelines and details.

FDA passed on the opportunity to commit to specifics several times, but please don't read these side-steps as a signal that the important questions are still unresolved. It's just a nod to process.

After all, here we all are at this big important public meeting where it's FDA's job to hear from interested parties. If they announce final rules before anyone else speaks, it sort of puts the lie to the whole purpose of the meeting, doesn't it?

FDA already has some idea of what they're going to do and Dr. Mansfield talked about several of these:

  • Lab tests will face risk-based regulation. 

  • FDA will regulate tests based on intended use. 

  • FDA acknowledges that LDTs will require some special considerations, but mostly expects that the IVD paradigm for assessing risk is a reasonable starting point.

This is all pending whatever new information FDA hears from industry the next couple days, of course.


Tags: CDRH, CLIA, Enforcement, FDA, IVD, Industry, LDTs

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