FDA issues guidance on its digital health regulatory policies
The Food and Drug Administration today released for comment clarifying what types of clinical and patient decision support software would no longer be regulated by the agency as a medical device under the 21st Century Cures Act. FDA Commissioner Scott Gottlieb, M.D., the guidance generally excludes from regulation software that allows a health care provider or patient to independently review the basis for its treatment recommendations. In addition, FDA released clarifying that certain digital health technologies, such as mobile apps intended solely to maintain or encourage a healthy lifestyle, generally fall outside the scope of FDA regulation under the Act, and adopting international principles for harmonizing the regulation of software with a medical purpose.