The 21st Century Cures Act of 2016 deregulated certain medical software, including:

•  Software that supports administrative functions like billing or reimbursement
•  Software that encourages a healthy lifestyle,
•  Software that serves as electronic patient records,
•  Software that assists in displaying or storing data, and
•  Software that provides limited clinical decision support

According to CDER, these types of software will no longer be considered or regulated as a medical device. Other types, such as mobile medical apps (defined as an app used as an accessory to a regulated medical device, transforming a mobile platform into a medical device [for example, an app that uses an attachment to a mobile phone to measure blood glucose], or performing sophisticated analysis or interpreting data from another medical device, particularly when guiding patient treatment), will be regulated as medical devices using the appropriate application path determined by the device’s category. Readers should note that software not considered a medical device by the FDA may still fall under the regulatory oversight of another agency, and you should use the FTC’s Mobile Health Apps Interactive Tool to determine the appropriate regulatory path. Read my earlier post on the Interactive Tool here.

Text Copyright © 2018 Katrina Rogers