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) is the primary federal agency responsible for safeguarding public health by ensuring the safety, efficacy, and security of a wide range of products, ...

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 ...

The US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as Class I following reports of four patient deaths. A Class I recall is the ...

The camera by itself is probably only a class II medical device because there are other similar cameras out there already. Beyond the fancy camera, however, the system is basically a computer with ...

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 ...

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...