FDA Announces New Procedures for CDRH Advisory Committees
This post was written by Paul Sheives.
FDA has announced changes in the procedures for advisory committees considering medical devices under review for premarket approval, effective May 1, 2010. The changes address staffing issues, voting procedures, and other items related to information presentation and flow of discussion. Among other things, rather than focusing on whether a device should be approved, which is solely in FDA’s discretion, the panels will now vote on only the safety and effectiveness of the device. FDA believes that this change is intended to narrow the focus of the advisory committees and prevent confusion regarding complicated regulatory nuances.
