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FDA Publishes Final Refuse To Accept Guidance

Today, FDA released the final version of its guidance document, relating to its Refuse to Accept (RTA) policy. The document, “Refuse to Accept Policy for 510(k)s,” dated January 30, 2018, is intended to outline the procedures and criteria that FDA will be using to assess whether the 510(k) submissions it receives meet the minimum requirements for substantive review. The agency released this information in hopes of streamlining the 510(k) process and ensuring that the substantive review process is more efficient. It is also intended to help submitters better understand FDA’s administrative review.

Previous versions of the RTA guidance documents, according to the agency, simply spelled out broad issues and principles relating to the RTA policy, but did not address “specific content that is essential for 510(k) review.” As a result, reviewers found themselves wasting time on inadequate submissions, which consumed the agency’s resources.

Review Process

The 510(k) acceptance review is meant to assess whether a submission has all of the administrative elements necessary for substantive review. The agency included checklists for Traditional, Abbreviated, and Special 510(k)s in the guidance document to help reviewers conduct their acceptance reviews.

When a submission is received, FDA will have no more than 15 days to review the submission for administrative completeness. If the submission is lacking one or more elements, the reviewer may request the information interactively (via e-mail) or put the submission on hold for up to 180 days to allow the submitter to provide the needed information. When the submitter forwards the requested documentation, the agency will have another 15 days to determine administrative adequacy. If the provided documentation is not complete, FDA will notify the contact person on file and provide a new checklist indicating the missing items.

If FDA does not provide feedback regarding administrative adequacy within 15 days, the submitter will be notified on day 16 that the submission has entered substantive review.

FDA’s Review Clock

FDA’s review clock begins at the time a submission is deemed to be complete for substantive review. If a submission passes the first 15-day completeness evaluation, day one of FDA’s review clock is the date the Document Control Center received the submission. If the 510(k) is refused during the 15-day completeness assessment, the agency’s review clock will not begin until the Document Control Center receives the submission or additional information that results in an acceptance designation for the 510(k). The 15 days the agency uses to conduct its administrative completeness review are included in the 60 calendar days that the agency is allowed to conduct its substantive review (according to MDUFA III).

The agency notes that FDA should consider only the presence or omission of the element or a rationale for the omission of the element or use of an alternative approach during the acceptance review. For example, if information, such as a test report, is provided, but is inadequate, the reviewer should mark the item as present and contact the submitter for additional information over the course of the substantive review. The test report would not be reviewed for adequacy during the 15-day administrative completeness review.

The complete guidance document pertaining to FDA’s Refuse to Accept Policy has been published by FDA and can be found at this link:

IUVO Consulting helps companies submit 510(k)s to FDA. For more information about our 510(k) submission service, please contact us by e-mail ( or by phone (+1-757-514-1589).

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