Make Sure the Medical Device You Choose Is Designed for You
MedSun: Newsletter #39, August 2009

FDA Device Regulation and Guidance

This checklist is designed for health care professionals and patients to use when choosing the best medical device to meet patients' needs. When selecting a device, it is important to consider how the environment and how the users capabilities may contribute to the safety and effectiveness of a device.

Additional Information:

Make Sure the Medical Device You Choose Is Designed for You. FDA Device Regulation and Guidance. July 18, 2000.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/ucm128206.pdf


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