Regulatory News In Brief
This article was originally published in The Gray Sheet
Federal and state regulatory news updates.
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The FDA letter cites Stryker for failing to notify FDA of a product recall and for illegally marketing devices, including the Neptune waste management system.
House Majority leader floats device tax repeal as fiscal cliff issue. The U.S. Preventative Services Task Force issued draft recommendations with middling support for hepatitis C screening in the general baby-boomer population. More news.
Orthofix settles foreign bribery charges. Cardiosolutions wins $8 million investment for mitral valve technology. OraSure plans $75 million stock offering. More news in brief.