FDAnews Device Daily Bulletin

FDA Calls for Stricter Controls on All Metal-on-Metal Hips

Jan. 22, 2013
Manufacturers of metal-on-metal (MoM) hip implants will need to file premarket approval applications proving the devices are safe and effective in humans, under a proposed order published by the FDA. The proposal — which applies both to MoM hips that include a cemented acetabular component and those that do not — would move the devices from Class II to Class III and require companies with products already on the market to go back and obtain premarket approval.
Devices & Diagnostics Letter