FDA Gets Support for Proposal Requiring PMAs for Metal-on-Metal Hip Implants

Consumer groups and a surgical association said they support the Food and Drug Administration’s proposal to require manufacturers of metal-on-metal (MoM) hip implants to submit premarket approval (PMA) applications.

The PMA process requires manufacturers to conduct clinical trials and is the most stringent standard for allowing devices on the market.

Consumers Union, the American Academy of Orthopaedic Surgeons (AAOS), and the National Research Center for Women & Families told FDA in comment letters that requiring a PMA submission is the best way to keep patients safe.

The agency’s proposed order “will finally require manufacturers to demonstrate clinical testing for safety ...