Re: Can one question a 510(k) decision
you may request the whole 510(k) file under Free Information Act. But it will take a long time to get.
Part of the reason why FOIA requests for regulatory action information take so long is that the applicant is notified and given an opportunity to propose any redactions that they can justify as unnecessarily disclosing proprietary information.
The bar is very low on such redactions...the internal FDA guidance, because the FDA is more directly governed by the FDC Act than by the FOI Act, is to lean toward accepting pretty much any such justifications.
In practice, many such 510(k) FOIA requests are a lot of work to pursue, resulting in receipt of not much more than a few odds and ends that don't include the parts that were of interest in the first place.