The FDA’s system for regulating software as a medical device (SaMD) under 21st Century Cures
- The statutory definition of what is – and what is not – a medical device: The 2016 21st Century Cures Act updated provisions in the Federal Food, Drug and Cosmetic (FD&C) Act to better clarify what types of software are considered to be within the FDA’s regulatory purview as a medical device. Importantly, that statutory update categorized whether products were in or out of the regulatory scope of the FDA’s oversight by function – meaning that a single software product could have multiple functions, some of which may be medical devices while others are not medical devices.
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