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FDA Awash In Adverse Events: All-Time High Of 1.5 Million MDRs Reported In 2017

 
• By Shawn M. Schmitt

US FDA statistics shared with Medtech Insight show that the number of Medical Device Reports sent to the agency dramatically rose last year, both in individual and summary formats. Might the agency's upcoming Voluntary Malfunction Summary Reporting Program slow the overall number of MDRs this year?

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Device-users and companies had the dubious distinction of making history last year by sending the largest number of Medical Device Reports ever – nearly 1.5 million – to US FDA.

Statistics shared with Medtech Insight by the Office of Surveillance and Biometrics (OSB) within the agency's Center for Devices and...

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More from Policy & Regulation

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