Before Responding to 483 Findings, Ask FDA For Concurrence
[Thursday, February 21, 2019]

Medical device manufacturers will be able to send their proposed actions to address audit findings to FDA before formally implementing them, thereby avoiding unnecessary back and forth with the FDA. An FDA 483 lists all the findings of non-compliance at the audited site with the requirement that the manufacturer address all findings adequately within a reasonable time. It greatly helps if the manufacturer can ask FDA if its actions to address the findings are acceptable before implementing the same. So far, manufacturers generally ask the FDA to comment regarding their proposed remedial actions but are not guaranteed that FDA will provide guidance within a defined time or if any response will be provided. The best course of action is simply doing your best and hoping for the FDA to accept creating anxious times of uncertain outcome. For medical devices, at least, now the process of getting FDA’s feedback, prior to implementation, is formalized. Manufacturers can send their request to FDA for comments within 15 days of getting an FDA 483, and FDA will respond within 45 days. To get a formal feedback, the audit findings must be those that would create safety issues, if not addressed. The requester must list all the findings with the proposed remedial actions. FDA’s feedback will be non-binding and although FDA still reserves the right to reject the remedial actions in subsequent audits based on new findings but the likelihood of that is expected to be rare. Manufacturers can also make changes to their proposal after getting FDA comments, again that would be rare. In short, the process will assure that the manufacturers and FDA come to a pre-agreement about the adequacy of the remedial actions prior to implementation. The guidance document is only about medical devices, but the same kind of advice can also be sought by manufacturers of drugs and biologics, however, in those cases due to the lack of a formal process, FDA may not respond in time or not respond at all. One can assume that in major safety related cases, FDA will, and that’s where it really matters.