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Makers Of An Array Of Devices Can Now Report Malfunctions In Summaries To FDA. Did Your Product Make The Cut?

 
• By Shawn M. Schmitt

US FDA rolled out its Voluntary Malfunction Summary Reporting Program on Aug. 17, allowing device-makers and manufacturers of device-led combination products to send quarterly rollup adverse event reports to the agency. The program's overarching goal is for FDA to receive fewer individual Medical Device Reports and to lessen the time firms spend preparing them, while maintaining sufficient detail for the agency to effectively monitor devices.

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Device-makers can now send periodic rollup reports of product malfunctions to US FDA for a wide range of products.

The Voluntary Malfunction Summary Reporting Program, as detailed in an Aug. 17 Federal Register notice, addresses goals outlined in a 2016 MDUFA IV commitment letter that directed the...

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More from Policy & Regulation

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