We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Cures Act Encourages Breakthrough Devices, Exempts Medical Software
Cures Act Encourages Breakthrough Devices, Exempts Medical Software
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.