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What is a medical device? Are we talking about things like thermometers, wheelchairs, and surgical knives. Is this saying you need a double-blind study for ever
by gersh 9y ago
What is a medical device? Are we talking about things like thermometers, wheelchairs, and surgical knives. Is this saying you need a double-blind study for every new design of wheelchair?
- HeyLaughingBoy 9y agoSometimes. No. Yes. No. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan... Sometimes the medical device is software. In fact, there are many software products on the markets whose makers don't even realize are unapproved medical devices. However, the FDA just doesn't have the manpower to investigate that on a wide scale.