An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of a medical device. Subtitle F deals with Medical Device Innovations. 21st Century Cures Act.

See also: FDA Draft Guidance: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act