After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...

Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...

The FDA is flagging a high-risk issue with blood glucose monitors manufactured by Trividia Health that the company says is tied to 114 serious injuries and one death since the devices’ launch 12 years ...

It’s no question that technology is expanding at a rapid pace, impacting devices in all fields, from manufacturing to medicine. When new developments come to fruition in the medical space, companies ...

The US Food and Drug Administration (FDA) is removing a limitation on the use of real-world evidence (RWE), clearing the way for de-identified data to be used for medical device submissions. Stating ...

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...