Is My Product A Medical Device

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U.S. Food and Drug Administration

U.S. Food and Drug Administration

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This CDRH Learn module defines what FDA considers to be a medical device; reviews various topics to consider when determining if your product meets the regulatory definition of a medical device; examines a device determination example; and lastly, identifies informal and formal ways for you to request assistance. To view more medical device educational resources please visit www.fda.gov/tr...

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