1. Medtech Insight

9 Manufacturer Volunteers Needed For FDA Malfunction Reporting Pilot Program

As part of a Congressional mandate, the agency is developing a program that would enable it to receive device malfunction summaries and publish them publicly. However, before implementing the program it is asking for volunteers to run a pilot program to better understand what requirements it should consider.

FDA is looking for nine manufacturers to volunteer in a pilot program to report device malfunctions in a more succinct form that would make it easier for the agency to track potential problems and publish them to the public.

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