FDA Introduces New 510(k) Refuse to Accept Policy

January 10, 2013

On Dec. 31, 2012, FDA released new Guidance for Industry (Guidance) on its Refuse to Accept Policy for 510(k) notifications (RTA Policy), which looks at the administrative completeness of submitted materials in order to begin substantive review. The Guidance sets out the procedures and criteria the FDA intends to use in assessing whether a 510(k) meets a minimum threshold of acceptability and therefore FDA should accept the submission. In particular, the Guidance states that FDA has modified its 510(k) RTA Policy to include early review against specific acceptance criteria and to inform the submitter within 15 days of receipt of the submission if the submission is administratively complete. Once administratively complete, the 510(k) will proceed as usual through substantive review.

The Guidance includes three acceptance checklists FDA will use to determine whether the submission meets the objective criteria required during the acceptance review, one each for traditional, abbreviated, and special 510(k)s. If FDA identifies missing information, the FDA will provide the submitter with a copy of the completed checklist indicating the missing items.

Furthermore, if an RTA designation is provided to the submitter, the “review clock” does not start until the submission meets all objective criteria required during the acceptance review.

If you have questions regarding this new FDA guidance or 510(k) submissions to the FDA, please contact one of the authors.