The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk, and released final guidance on the types of software no longer considered medical devices under the Act’s amended definition of device. “We’re making clear that certain digital health technologies — such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle — generally fall outside the scope of the FDA’s regulation,” said Principal Deputy Commissioner Abernethy, M.D. “Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the health care system.”

Related News Articles

Headline
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations…
Headline
Sens. Dick Durbin, D-Ill., and Marco Rubio, R-Fla., today introduced AHA-supported legislation that would reauthorize the mandatory portion of the National…
Headline
The White House today released additional details related to President Biden’s budget request for fiscal year 2024. The main budget documents were released…
Headline
The U.S. District Court for the District of Connecticut this week largely dismissed a lawsuit alleging that Yale New Haven Hospital violated its fiduciary…
Headline
In comments submitted today, AHA encouraged the Department of Health and Human Services to finalize as written its proposed rule regarding statutory conscience…
Headline
Following a Feb. 6 court decision that vacated nationwide the federal government’s revised independent dispute resolution process for determining payment for…