In January 2024, the Government Accountability Office (GAO) formally accepted a request from Congress to review FDA’s oversight of device recalls. To inform the forthcoming investigation, this ...

The uses identified in its general regulatory classification, if it is a medical device exempt from pre-market review. The uses cleared or approved by the FDA. Its target patient population.

The Biden administration is considering creating a quicker process to review new medical devices for Medicare coverage after a controversial Trump-era rule was scrapped. Officials with the Centers ...

For some medical devices, the FDA requires data from studies in people to show that the device, including things like implantable heart defibrillators or stents, is safe and effective.