Business · 06/09/2002

FDA Denies Petition to Reclassify Orthopedic Devices, Citing Lack of New Information

The FDA has denied a petition by the Orthopedic Surgical Manufacturers Association to reclassify two types of hip joint metal/metal semi-constrained prostheses, citing a failure to provide new information that would establish the need for special controls to ensure their safety and effectiveness.