The Food and Drug Administration today released for comment draft guidance clarifying what types of clinical and patient decision support software would no longer be regulated by the agency as a medical device under the 21st Century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 In addition, FDA released draft guidance clarifying that certain digital health technologies, such as mobile apps intended solely to maintain or encourage a healthy lifestyle, generally fall outside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

Related News Articles

Headline
The FBI Aug. 20 released an advisory warning of malicious activity by Russian cyber actors targeting end-of-life devices running an unpatched vulnerability in…
Headline
The Department of Health and Human Services and the Centers for Medicare & Medicaid Services Aug. 21 announced the creation of a Healthcare Advisory…
Headline
The Cybersecurity and Infrastructure Security Agency, Environmental Protection Agency, National Security Agency, FBI and international agencies Aug. 13…
Headline
Josh Neff, CEO of CommonSpirit Mercy Hospital, discusses a new cutting-edge communication platform that sends patient EKGs directly from the ambulance to the…
Headline
The Department of Justice Aug. 11 announced a series of actions taken against the BlackSuit ransomware group, also known as “Royal,” including the disruption…
Headline
The National Institutes of Health Aug. 5 issued guidance to researchers on the use of artificial intelligence for the research application process. According…