SaMD

Health Innovation June 5, 2018

FDA Asks for Input on Software That Isn’t a Medical Device

By William A. Hyman – It has long been clear that the FDA can regulate software that falls under the definition of a medical device. Such software might be part of and integral to a more physical chunk of technology.

Healthcare Revenue Cycle and Finance October 3, 2017

Industry Coalitions: The Key to Advancing Medical Software Regulations

By Kristen Hopewell – Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”