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

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

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

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness trackers.

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

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.

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...

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 ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

(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 ...