FDA panel discusses hip protocols
This article was originally published in Clinica
Executive Summary
Industry representatives recommend that the US FDA should not require more than a two-year follow-up in clinical trials for new or novel hip systems. The Health Industry Manufacturers Association and the Orthopaedic Surgical Manufacturers Association aired their views on proposed changes to clinical protocols at the agency's Orthopaedic and Rehabilitation Devices Advisory Panel on June 12th.