www.fdanews.com/articles/134359-medical-device-software-regulations-to-be-relaxed-fda-decides

Medical Device Software Regulations to Be Relaxed, FDA Decides

February 16, 2011

The Food & Drug Administration exempts certain hardware and software products for medical devices from pre-market review. The Food & Drug Administration loosened regulations for certain hardware and software products for medical devices.
MedCity News