The Role of FDA in Health Care Software Regulations and Development
September 24, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Overview: This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device Why should you Attend: Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing process (not necessarily a medical device, but like all device class II and III, manufacturing elements, subject to QSR’s), or 2) software that is a component or accessory of some Class III or Class II medical device (Itself a medical device, per FDA guidance). Also, with the proliferation of numerous applications in the Health Care, some developers are still unsure whether or not their product is a medical device. Finally, even though some applications can meet the definition of a medical device, Guidance indicates that FDA is not going to regulate them. Can you tell which is which? Compliance4All Adam Fleaming Phone: +1-800-447-9407 support@compliance4all.com www.compliance4all.com