The proposed rule would (1) define ‘‘517A decision,’’ (2) apply to requests submitted to the Center for Devices and Radiological Health (CDRH) for review of 517A decisions and decisions other than 517A decisions made by CDRH, and (3) establish timelines and procedures for an interested person to request supervisory review of these decisions by CDRH. By setting specific timelines for persons to submit requests for supervisory review, the proposed rule would help clarify the supervisory review process and provide firms with an incentive to promptly submit review requests. The proposed rule would also establish timelines for CDRH review of 517A decisions, reducing uncertainty about when interested persons would know the outcome of their requests for supervisory review. Because the proposed rule would not change the effort needed to prepare and submit a request for supervisory review, we anticipate that affected interested persons would incur only negligible costs to read and learn about the provisions of the proposed rule. We do not expect additional costs for FDA.

We received 42 requests for review in 2013, 28 requests for review in 2014, 20 requests for review in 2015, and 20 requests for review in 2016. We estimate that each request for review required 70 hours of CDRH staff time. One possible benefit of the proposed rule, if finalized, is that it may reduce the number of hours required per request for review. If firms have more clarity about the request for review process, they may not have to spend as much time navigating the process, and we may not need to spend as much time guiding them through the process.

Federal Register: January 17, 2018
Docket: FDA-2016-N-2378