Devices & Diagnostics Letter

Oct. 15, 2012 | Vol. 39 No. 41

Industry Seeks More Clarity on 510(k) Refuse-to-Accept Draft Guidance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.

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IMDRF Unveils Global UDI Scheme; Core Concepts Endorsed in EU Recommendation Standardized Device Labeling Still An Undefined Concept: Stakeholders FDA Seeks Industry’s Help at Second Crack on 510(k) Device Change Policy Dispute Over Who’s to Blame for 510(k) Problems Impeding Reform Efforts

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