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FDA Proposes PMAs For Metal-On-Metal Hips

Spurred by heightened adverse event and revision rates, FDA is proposing enhanced pre-market requirements for all metal-on-metal hip implants.

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...

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