FDA Proposes New Premarket Approval Filings for Metal-on-Metal Hip Devices

WASHINGTON, D.C. — The U.S. Food and Drug Administration said Jan. 17 it is proposing to require manufacturers of two categories of metal-on-metal hip implant devices submit premarket approval applications or complete a product development protocol for FDA review.

The FDA said it did not anticipate reclassifying the metal-on-metal devices to require stricter “special controls,” however.

The two devices listed in the notice to be published Jan. 18 in the Federal Register are “Hip joint metal/metal semi-constrained, with a cemented acetabular component,” and “Hip joint metal/metal semi-constrained, with an uncemented acetabular component.”

The FDA said in a pre-publication notice of …