An Introduction to FDA's Regulation of Medical Devices



This CDRH Learn module explains FDA’s role in regulating medical devices. It provides the definition of a medical device and describe the steps to bring a new product to the U.S. market and the different types of premarket regulatory submissions that might be required by FDA. To view more educational resources please visit https://www.fda.gov/training-and-continuing-education/cdrh-learn

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