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Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance
Devicemakers praised FDA efforts to craft guidance on the agency’s refuse-to-accept policy for 510(k) premarket notification submissions, but took issue with many specifics, including what would happen if a backlog causes the FDA to miss its proposed 15-day timeline. The draft guidance, “Refuse to Accept Policy for 510(k)s,” was issued in August, with comments due Sept. 27.
Devices & Diagnostics Letter |
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