Spurred by heightened adverse event and revision rates, FDA is proposing enhanced pre-market requirements for all metal-on-metal hip implants.
FDA Proposes PMAs For Metal-On-Metal Hips
Article preview from "The Gray Sheet" - January 21, 2013
FDA is proposing new pre-market approval requirements for all metal-on-metal hip implants, including the submission of clinical data demonstrating safety and effectiveness of their products.
The Jan. 17 proposed order
would require manufacturers of existing products to submit new marketing applications in order to keep their devices on the market. Future metal-on-metal hip technologies would also have to go through the PMA route.
The proposal was released in conjunction with an FDA safety communication to orthopedic surgeons recommending that they conduct metal ion testing and imaging examinations for metal-on-metal hip patients who show adverse symptoms.
Metal-on-metal implants have entered the U.S. market via the 510(k) pathway for years. They are among the remaining class III pre-amendment device categories that can still rely on 510(k)s. The devices have been the subject of much international scrutiny due to reports of increased adverse event and revision rates compared to non-metal-on-metal hip implants.
The proposed order would require PMA submissions that demonstrate “an independent showing of the safety and effectiveness of a device, based on valid scientific evidence,” explained CDRH Chief Scientist William Maisel in a Jan. 16 interview with “The Gray Sheet.”
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