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FDA Asks For More Summary Adverse Event Reports Under Proposed MDR Program

 
• By Shawn M. Schmitt

The US agency has proposed a Voluntary Malfunction Summary Reporting Program that will allow makers of an array of devices to submit Medical Device Reports in a summary, rather than individual, format to FDA. The program aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility.

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Makers of an array of devices will soon be able to submit Medical Device Reports in a summary format to US FDA thanks to an upcoming program that aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility of problem products.

Submitting reports under the Voluntary Malfunction Summary Reporting Program "would provide the most compact and efficient reporting mechanism for streamlining...

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