The U.S. Food and Drug Administration (FDA) has published an updated list of consensus standards the agency recognizes as part of its premarket review of medical devices.
According to its 2007 Guidance, “Recognition and Use of Consensus Standards,” the FDA believes that “conformance with recognized consensus standards can support reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.” As a result, manufacturers typically submit evidence of compliance with FDA-recognized consensus standards as part of their pre-market submission for new medical device approvals.
The updated list of consensus standards was published in late August in the Federal Register, and includes additions, withdrawals, corrections and revisions of certain consensus standards recognized by the FDA. Read the updated list as published in the Federal Register.
