Proposed 510(k) Changes Elicit Some Industry Skepticism
Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.
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FDA is recruiting companies to participate in a 510(k) pilot program for optical coherence tomography (OCT) devices. This is the third 510(k) pilot program announced in recent months.
US FDA released a draft guidance on the special 510(k) program in an effort to expand and improve the pathway.
The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.