Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

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 ...

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

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

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.

Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...

By Puyaan Singh Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing ...

(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 ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...

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