In a stunning development leaked this week to the media, a senior Food and Drug Administration source told journalists that the FDA plans to begin regulating as medical devices certain mobile phones, fax machines, pagers, and some models of egg timers used by healthcare providers for communication and care coordination within the next year.
………… Fake News!!
The truth is that over the past 5 years, there has been a deregulatory trend in the US with regard to low-risk healthcare software, and the 21st-Century Cures Act (2016) is the latest in that trend. Specifically, the Cures Act provides that software for healthcare communication and logistics does not meet the FDA’s “medical device” definition, or classification, and is therefore not subject to FDA regulation. The FDA classifications for software as a medical device are based on the intended use of the application and the risk it presents to patient safety.