FDA issues guidance on its digital health regulatory policies

The Food and Drug Administration today released for comment draft guidance clarifying what types of clinical and patient decision support software would no longer be regulated by the agency as a medical device under the 21st Century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., said 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 In addition, FDA released draft guidance clarifying that certain digital health technologies, such as mobile apps intended solely to maintain or encourage a healthy lifestyle, generally fall outside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 final guidance adopting international principles for harmonizing the regulation of software with a medical purpose.