New FDA Guidance for Medical Device 510(k) Submissions
On Sept. 13 the FDA released FOUR new final guidance documents relating to 510(k) submissions - guidelines for traditional, abbreviated, special 510(k). They appear to be really harmonizing and solidifying the overall expectations for these submissions. As the names imply, these are not draft guidance documents, so expect that they will be enforced soon. Check out the official documents at the link below:
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