FDAnews
www.fdanews.com/articles/134441-fda-finalizes-regulation-for-medical-device-hardware-software

FDA Finalizes Regulation for Medical Device Hardware, Software

February 18, 2011
The FDA Monday announced a rule that eases the path to market for certain hardware and software products used with medical devices. The new rule classifies these products, also known as Medical Device Data Systems, as low-risk or Class I devices, and the new ruling exempts these products from premarket review. Prior to the FDA’s new ruling, which was first proposed in 2008, these products were considered high-risk, Class III devices, and were subject to premarket approval.