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# Guide on 510(k) Refuse to Accept Policy
- URL: https://www.fdaweb.com/guide-on-510-k-refuse-to-accept-policy/
- Published: 2022-04-22T12:00:00.000Z
- Updated: 2026-09-14T17:41:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151658

FDA has released a [final guidance](https://www.fda.gov/media/83888/download?ref=fdaweb.com) entitled *Refuse to Accept Policy for 510(k)s* that outlines the procedures and criteria the agency intends to use in assessing whether a medical device premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The document explains the agency’s early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s). Additionally, it includes checklists and clarifies required elements and contents of a complete 510(k) submission.