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Final Guidance Details FDA’s Summary Reporting Program

 
• By Elizabeth Orr

The VMSR program allows manufacturers of many low-risk devices to report adverse events on a quarterly basis. 

The US Food and Drug Administration has finalized a guidance document detailing a program that lets makers of eligible devices report some malfunctions in a summarized quarterly format.

Typically, device manufacturers are required to file Medical Device Reports (MDRs) every 30 days. But the Voluntary Malfunction Summary Reporting (VMSR) program allows eligible companies to report most device malfunctions...

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More from Policy & Regulation

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• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
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