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FDA Publishes Draft Guidance on "Refuse to Accept" 510(k) Policy BY LAUREN UZDIENSKI, AUGUST 21, 2012

The FDA released draft guidance last week on a new "refuse to accept" policy for 510(k)s. The policy would implement an additional layer of preliminary review for 510(k)s to certify that an application "meets a minimum threshold of acceptability and should be accepted for substantive review." The initial review is largely administrative and designed to identify missing or incomplete components of an application. The FDA said they would notify the applicant of the outcome of this preliminary review within 15 days of receiving the 510(k).

The review will take the form of a 37-point checklist, which is included in the draft guidance. Items range from "Is the product a device?" to questions about the completeness of clinical and biocompatibility data. The FDA says this process will enable them to focus their review resources on complete applications, thus accelerating the review process, and will help the agency encourage "quality submissions" from companies.

The FDA cites the new user fee legislation, which includes review-time-based performance goals, as one reason for establishing the new refuse-to-accept regulations. The agency will accept comments on the draft guidance for 45 days.

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