The FDA released the new provisions in an April 19 document in the Federal Register. The guidance outlines the software functions that are no longer considered medical devices under the FDA’s updated definitions.
Here are the eight software functions that are now excluded from the classification of a medical device:
- 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 communication system
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