On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

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 ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not operate this way; it is built to evolve.

Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development ...

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...

FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA ...