FDA seeks input on medtech adverse-event reporting proposal

07/10/2013 | MassDevice.com (Boston)

Draft guidance on how manufacturers should report certain adverse events related to medical devices has been released by the FDA and is open for comment for 90 days. The guidance addresses common reporting mistakes made by medtech companies, such as including multiple adverse events or more than one device in one report.

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MassDevice.com (Boston)

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