JD Supra

Regulation of Digital Health Products by FDA

Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, ...
JD Supra

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
Forbes

FDA Medical Device Security SBOMs: While Great, Don’t Rely On Them Alone

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
Business Wire

EU MDR, EU IVDR & FDA Medical Device Software Compliance and Regulations Course (LIVE ...

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 ...
FierceBiotech

FDA formally kicks off medical device user fee negotiations

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...

FDA commissioner says non-medical-grade wearable data exempt from regulation

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...
Medical Device and Diagnostic Industry (MD+DI)

FDA’s New Rules for Wearables

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

FDA exempts more wearable, AI features from oversight

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
GlobalData 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 ...
Arabian Business

FDA exempts non-medical-grade wearable data devices from regulation

These technologies are improving all the time. If they’re not making claims that they are medical grade, let’s let the market ...