FDA moves to update its refuse to accept policy for 510(k) notices

The Food and Drug Administration (FDA or “the agency”) announced on 13 August the publication of a refuse to accept (RTA) policy for 510(k) premarket notifications (“510(k) notice”). When final, this draft guidance document will supersede the following agency guidance documents, which are outdated and rarely adhered to by FDA: (1) Center for Devices and Radiological Health’s premarket Notification (510(k)) Refuse to Accept Policy (30 June 1993), and (2) 510(k) Refuse to Accept Procedures (K94-1) Blue Book Memo (20 May 1994).

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