www.fdanews.com/articles/167116-devicemakers-ask-fda-to-exempt-health-it-from-qs-regulations
Devicemakers Ask FDA to Exempt Health IT from QS Regulations
September 12, 2014
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function.
The GMP Letter