Topic - FDA

While most medical devices go on the market without clinical studies, high-risk ones that undergo pre-market approval need what’s called an “investigational device exemption” from the Food and Drug Administration, said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, who studies high-risk devices.

Third patient got a Neuralink brain implant, Elon Musk says. The work is part of a booming field →

Their websites often look like legitimate e-commerce platforms, often with false claims that they are approved by the Food and Drug Administration, said the report, released Wednesday.

U.S. 'notorious markets' report warning of risks from online pharmacies →