Good news! Eight software functions no longer classified as medical devices under FDA.

Good news for medical device designers. FDA is amending classification regulations as a result of changes made by the 21st Century Cures Act to the Federal Food, Drug, and Cosmetic Act (FD&C Act). These remove certain software functions from the definition of a device  “including software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images or other clinical information.” The changes apply to software in the following devices and systems:

Calculator/Data Processing Module for Clinical Use
Continuous Glucose Monitor Secondary Display
Automated Indirect Immunofluorescence Microscope and Software-Assisted System
Medical Device Data Systems
Home Uterine Activity Monitor
Medical Image Storage Device
Medical Image Communications Device
Picture Archiving and Communications System (PACS)

Read more in the Federal Register. Hat tip to HISTalk Monday Morning Update