FDA finalizes streamlined bundled, quarterly MDR reporting system

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FDA 3D printingThe FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting.

The program was created in part through public comments received by the FDA and is intended to allow manufacturers to report “certain device malfunctions in summary form on a quarterly basis” instead of an an individual basis for certain devices.

Read the whole story on our sister site, MassDevice.com

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