FDA has issued a draft guidance, Recognition and Withdrawal of Voluntary Consensus Standards, and a final guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, and will hold a 10/25 Webinar on the final guidance. The draft document was developed to provide guidance about the procedures CDRH follows when it receives a request for recognition of a voluntary consensus standard. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, and reasons and rationales for withdrawing a standard.
The finalized document describes the appropriate use and documentation of both FDA-recognized and non-recognized consensus standards for premarket submissions and how agency staff intends to rely on consensus standards during the review process. It provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions. Information before and after the Webinar on the finalized guidance will be posted here.