Court Declares FDA Cannot Place A Use-Specific Ban On Medical Devices

By Kelly Lienhard / July 8, 2021 at 1:50 PM
A federal appeals court on Tuesday (July 6) overturned FDA’s ban on the use of electric shock devices to treat patients with self-harming behaviors -- a ruling that regulatory lawyers say could further limit FDA’s ability to make decisions about marketed medical products without interfering with the practice of medicine. In its 2-1 decision, the court asserted FDA doesn’t have authority to ban an approved medical device for one specific purpose but not another. The court said it would need...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.