FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less regulatory oversight.

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health technology and AI policies.

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

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

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 ...

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...

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 ...

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 ...

(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...