MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

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

FDA announces regulatory exemptions for 'non-medical grade' devices

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

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
Medical Device and Diagnostic Industry (MD+DI)

CGM Manufacturer Views FDA’s New Rules on Wearables as “Catalyst” for Accelerated Commercialization

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

Drug and Medical Device Regulation Under the Trump Administration

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 ...
Medical Device and Diagnostic Industry (MD+DI)

How Medical Device Companies Can Avoid Costly FDA Inspection Mistakes

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

Should Medicare automatically pay for medical devices that the FDA deems ‘breakthrough’?

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

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
JD Supra

Biological Products Regulation Part 3: Unlocking Reference Product Exclusivity: What Sponsors Need to Know

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

Chatbots Are Not Medical Devices

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
MobiHealthNews

How to avoid FDA mHealth regulation

(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 ...
Healthline

Which Products Does the FDA Regulate?

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 ...