Medical Devices (includes In Vitro Diagnostics)
Applied and Strategic
CDRH has recently published a final guidance document titled “Appropriate Use of Voluntary Consensus Standards for Premarket Submissions for Medical Devices” which describes the appropriate use and documentation of both FDA-recognized and non-recognized consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. CDRH has also published or is preparing to publish the following two FDA draft guidance documents:
• Recognition and Withdrawal of Voluntary Consensus Standards (Draft published on September 14, 2018)
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program (Draft to be published autumn, 2019)
In this session, FDA will explain regulatory frameworks, policies, and practices regarding the recognition and withdrawal as well as appropriate utilization of consensus standards for premarket submissions. We will also address issues on standards commonly seen in submissions and inquiries we have received related to standards use and conformity assessment. Furthermore, we will provide updates on the new ASCA pilot program.