agree, the FDA couldn't give clearance for general pain treatment since their current rules only allow them to give indications of use based on clinical data. the real world evidence rule change is not finalized yet (I suspect Trump will have it accelerated) so the UK survey is not admissible
it seems the company got FDA to say that if they had three different body parts supported by clinical evidence then they would issue a general clearance. That in itself is a big decision.
typical turn around for additional 510ks for recently cleared predicates is about 80 days I think - again Trump may speed things up
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