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U.S. Department of Health and Human Services

Medical Devices

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Acceptance Checklist for 510(k)s

The Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s describes the criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

The guidance includes acceptance checklists for each type of 510(k) submission: