Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to our analysis of the FDA's database of adverse ...

The Food and Drug Administration has finalized guidance on manufacturers notifying the agency of changes that could likely disrupt the supply of medical devices. Officials created the guidance to ...

a detailed analysis is required to determine whether software satisfies the definition of a medical device, fails to satisfy the definition of a medical device and is therefore outside of FDA’s ...

The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical ...

The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...

The Food and Drug Administration wants the developers of medical devices that rely on artificial intelligence to disclose much more detail about how their devices were developed and tested ...

The GAO report determined the FDA did not meet its foreign inspection targets between fiscal year 2018 and fiscal year 2023. “According to our analysis of FDA data, the number of foreign ...

The commercial manufacturing example involves an AI-based visual analysis ... FDA explains what documentation and information should be included in marketing submissions for devices with AI ...

A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics ...