Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA plans the imminent release of a white paper outlining a new national medical device post-market surveillance strategy in the lead up to public meetings Sept.10-13. More regulatory news below.
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Regulatory News In Brief
FDA issues final rule on good manufacturing practices for combination products. Rule withdrawn on scientific misconduct policy. More regulatory news.
FDA Unveils Plan To Strengthen Device Post-Market Surveillance
Combining new techniques with improvements to current tools, the strategy aims for "near real-time" post-market surveillance.
Final FDA Bill: Device Provisions
Congress has settled on final language for the FDA Safety and Innovation Act. After Senate approval, the bill will go to the White House for President Obama’s signature.