Data Questions Dominate Metal-On-Metal Panel; New Monitoring Recommended
This article was originally published in The Gray Sheet
Executive Summary
FDA advisory panel examines science behind controversial metal-on-metal hips, recommends new monitoring, possible label changes.
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Washington Roundup, January 2013
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposal to require PMAs for metal-on-metal hips, the launch of the Medical Device Innovation Consortium, CMS draft guidance on CED, and a recent analysis of the potential impact of the Affordable Care Act on device markets.
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.