MobiHealthNews

Commentary: FDA’s website has wrong information about the scope of its software regulation — and that's a big problem

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 ...
Business Wire

EU MDR, EU IVDR & FDA Medical Device Software Compliance and Regulations Course (LIVE ONLINE EVENT: November 18-21, 2024 / ON-DEMAND) - ResearchAndMarkets.com

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 ...
MobiHealthNews

Deloitte report offers guidance for FDA's upcoming software regulation pathway

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 ...
The Lancet

Bridging the gap: aligning clinical decision support regulation with clinical practice in the era of artificial intelligence

Clinical decision support (CDS) software plays an increasingly central role in health-care delivery, yet the ambiguous ...