A key section of the recently passed 21st Century Cures Act explained to the US Food and Drug Administration (FDA) which categories of software should be exempt from medical device regulations. Most ...
The guidance sets forth FDA’s 2015 policy on when mobile medical applications qualified as medical devices. But in 2016 the 21st Century Cures Act changed fundamentally the scope of FDA’s oversight of ...
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 ...
Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.
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 ...
Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations (June 22nd - June 26th, 2026)" training has been added to ...
The US Food and Drug Administration (FDA) is moving to relax regulatory requirements for low risk health and wellness wearables, software, and certain other non-medical grade devices. Outlining the ...
The Food and Drug Administration has told Whoop that it must get its wearable blood pressure tool approved as a medical device, but the Boston tech company is refusing to submit it to the agency for ...
FDA Commissioner Dr. Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation, as the agency moves to clarify its approach to ...
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