The FDA describes the Product Code Classification Database in the following way: "The Product Classification Database contains medical device names and associated information developed by the Center ...

Medical device classification should be a pretty simple exercise, but as with most regulatory matters, it's not always as straightforward as it seems. In an effort to shed some light on the FDA's ...

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

The Food and Drug Administration (FDA, Agency, or we) is classifying the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea into class II (special controls ...

On January 27, the U.S. Food and Drug Administration classified the recall as “Class I,” the most severe risk level. According to the FDA, “Class I” level recalls are used in situations ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...