Day

July 9, 2020
09
Jul

FDA Calls for Comment on Non-Device Software Functions

July 9, 2020
Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...
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