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 ...
The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental ...
Clinical decision support (CDS) software plays an increasingly central role in health-care delivery, yet the ambiguous interpretations of regulations result in inconsistent application in clinical ...
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 ...
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).
FDA Commissioner 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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