Cures Act Encourages Breakthrough Devices, Exempts Medical Software

By January 18, 2017 The GMP Letter No Comments

Manufacturing-related provisions in the recently enacted 21st Century Cures Act establish a program for “breakthough” devices, exempt some categories of medical software from regulation as a medical device, and require the FDA to publish a list of reusable device types that must include usage instructions and cleaning data.
Source: The GMP Letter