Washington Roundup, November-December 2012
Executive Summary
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover the post-election picture, pending reimbursement reductions for interventional cardiologists, and new guidance on PMA and 510(k) submission reviews.
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Device Industry Amps Up Efforts To Repeal Device Tax In Lame Duck Session
Industry groups flew in more than 50 CEOs to visit Capitol Hill, launched an ad campaign and released an impact report last week as part of a stepped-up effort to get Congress to repeal the impending medical device tax before it goes into effect Jan. 1.
Multiple MDUFA Policies In Transition Phase Until Jan. 1
For now, CDRH remains in a transition phase on its new refuse-to-accept policies for PMA and 510(k) submissions and its mandate for electronic copies of pre-market submissions, each of which have been addressed in recent guidance documents.
News In Brief
Allergan Lap-Band unit on the block? DOJ investigates Abiomed Impella marketing. St. Jude Medical expands job cuts. More news briefs.