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 navigate a growing pool of wearables.

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 ...

The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers

AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
Healio

FDA approves updated label with new dosing guidance for inhaled insulin

The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
JD Supra

FDA’s 2026 CDS and General Wellness Guidance Updates

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
JD Supra

FDA Adapts with the Times on Digital Health: Updated Guidances on General Wellness Products and Clinical Decision Support Software

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

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
National Law Review

FDA Updates Two Digital Health Final Guidance Documents

On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...
Becker's Hospital Review

AHA critiques FDA’s expanded regulation of clinical decision support software

The American Hospital Association released a statement expressing concerns about the FDA’s draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act ...
MobiHealthNews

How the FDA can improve regulation of mobile health, according to FDASIA workgroup

This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to ...
BioSpace

FDA’s Multiple Myeloma Guidance Highlights Decade of Success

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
MobiHealthNews

Should mHealth companies want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...