IMDRF Safety/Performance of Medical Devices/IVDs

The International Medical Device Forum, which FDA participates in, released a draft for comment entitled, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.  This guidance document describes fundamental design and manufacturing requirements, referred to as “Essential Principles of Safety and Performance” that, when met, indicate a medical device is safe and performs as intended.

IMDRF Safety and Performance

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