Friday, March 22, 2024 5:16:51 PM
By definition filing for medical device approval via a 510(k) relies on your product being basically a literal copy of an existing product on the market (a "predicate").
So you can believe that fountain of truth and light, Leo "the disappearing CEO" Ehrlich in one of his last public pronouncements before he vanished from public view, or you can believe the FDA:
https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectively-use-predicate-devices
Not a tough choice really.
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