Software Exclusions, Breakthrough Devices Featured in 21st Century Cures Act

Most of the provisions in the 21st Century Cures Act clarifying medical software regulation are straightforward and welcomed by industry, but it is unclear how the FDA will apply a provision on clinical decision support software.

Section 3060 of the Act exempts five categories of software from regulation as a medical device, including software used for administrative support, maintaining or encouraging a healthy lifestyle, electronic patient records, processing or displaying clinical data or related findings by a healthcare professional, and supporting or providing treatment recommendations.

The software exclusions “are welcome news to an industry that has been struggling with the question of whether its products are subject to FDA regulation,” said attorney Jeffrey Shapiro at Hyman, Phelps & McNamara. — Jeff Kinney