FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health technology and AI policies.
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS ...
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
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.
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 ...
DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes ...
Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
A recent report said medical device software is under-regulated and recommended the Food and Drug Administration develop procedures to ensure the safety and efficacy of products before they go to ...
A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial ...
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