To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be ...

The Illinois lawmakers want an electronic format for medical device makers to quickly and transparently report recall information to federal regulators.

December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...

The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...