Home > Newsletters > The QMN Weekly Bulletin > Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance
The QMN Weekly Bulletin
Oct. 19, 2012 | Vol. 4 No. 42
Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance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.
AdvaMed recommended the FDA modify the draft to ensure it asks that acceptance reviewers only look to see whether documents are present, rather than attempting to answer the more in-depth question of adequacy.
AdvaMed also asked the FDA to clarify whether failure to submit electronically would result in a submission’s rejection and to remove references to advertisements from the reviewer checklist.
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