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 ...

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

Here are three recent recalls reported to the FDA: ...

Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.