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FDA’s proposal to require PMAs for metal-on-metal hips, the launch of the Medical Device Innovation Consortium, CMS draft guidance on CED, and a recent analysis of the potential impact of the Affordable Care Act on device markets.
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Flaws in the 510(k) process prevented FDA from noticing high metal-on-metal revision rates, researchers write in the New England Journal of Medicine. Their argument is based on a predicate “ancestry” analysis of DePuy’s recalled ASR hip system.
FDA advisory panel examines science behind controversial metal-on-metal hips, recommends new monitoring, possible label changes.
The Medicare Evidence Development & Coverage Advisory Committee was charged May 16 with helping CMS better define the evidence threshold under which the agency should or should not pursue a coverage- with-evidence-development policy.