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FDA’s proposal to require PMAs for metal-on-metal hips, the launch of the Medical Device Innovation Consortium, CMS draft guidance on CED, and a recent analysis of the potential impact of the Affordable Care Act on device markets.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 is proposing new premarket approval (PMA) requirements for all metal-on-metal hip manufacturers including the submission of clinical data demonstrating safety and effectiveness of their products.

The January 17 proposed order was released in conjunction with an FDA safety communication providing recommendations to orthopedic surgeons on measures to take, including metal ion testing and imaging examinations,...

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