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FDA Draft Guidance Clarifies Rules Of Summary Reporting Program

 
• By Elizabeth Orr

The program allows manufacturers of most lower-risk devices to submit reports of known adverse events via quarterly summaries, rather than individually.

Digital representation of a networked server room.
• Source: Shutterstock

The US Food and Drug Administration has released a new set of recommendations intended to help eligible manufacturers use the Voluntary Malfunction Summary Reporting (VMSR) program to notify the agency about device malfunctions.

The agency says that the 9 December draft guidance document “is intended to further explain, but not change” VMSR...

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