Washington Roundup, January 2013
Executive Summary
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FDA’s proposal to require PMAs for metal-on-metal hips, the launch of the Medical Device Innovation Consortium, CMS draft guidance on CED, and a recent analysis of the potential impact of the Affordable Care Act on device markets.
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Researchers Push FDA To Raise Standards For Metal-On-Metal Hips
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.
Data Questions Dominate Metal-On-Metal Panel; New Monitoring Recommended
FDA advisory panel examines science behind controversial metal-on-metal hips, recommends new monitoring, possible label changes.
New Coverage-With-Evidence-Development Guidance In The Works Following MedCAC Meeting
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.