CDRH Clarifies Acceptance and Refusal Policies for 510(k)s and PMAs

February 6, 2018

CDRH updated its guidances on policies used for making determinations on accepting or refusing 510(k) submissions and premarket approval applications.

The guidance on 510(k)s and the one on PMAs supersede agency policies set forth in 2015 and 2012, respectively, prompted by commitments under the FDA Reauthorization Act of 2017 to base MDUFA IV performance goals on how long it takes to complete an application or submission review.

The guidances are intended to provide devicemakers a better understanding of the types of information required for a 510(k) to meet a “minimum threshold of acceptability” and for a PMA to be considered complete. Updates reflect a continued effort to make better use of FDA resources allocated for product reviews.

Both guidances are applicable to all medical devices reviewed either through a 510(k) submission or a PMA application, and new details for combination products are included.

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