When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel

Nearly five years ago, Congress directed FDA to set up an advisory panel to help resolve scientific disputes between the agency and industry. The result was the Medical Devices Dispute Resolution Panel. Operating under FDA’s Medical Devices Advisory Committee, the panel helps resolve product-specific scientific disputes between FDA and product sponsors. It then makes recommendations to the CDRH director, who makes the final decision on the matter.