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How do I determine if something is a “medical device” or an “investigational medical device?”

Medical devices range from the simple (e.g., tongue depressors and test kits) to the complex (programmable pacemakers and medical lasers). See the FDA’s website “How to determine if your product is a medical device.”

An investigational medical device is a device that is not lawfully marketed as a medical device OR a medical device that is lawfully marketed but will be used in clinical investigation outside its cleared or approved indications.

See FDA’s medical device databases, particularly Premarket Approval (PMA), 510k clearance, and De Novo. Note that it’s recommended to use only part of the name of the device or the manufacturer to successfully search the database.