April 19, 2021 – The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act.
The new provisions were released in an April 19 document in the Federal Register. Through this action, the FDA is amending eight classification regulations so that the regulations conform to the medical software provisions of the Cures Act and reflect FDA’s current statutory authority. The guidance outlines software functions that are no longer considered medical devices under the FDA’s updated definitions. This final rule does not change the classification of the device types for which FDA is amending the title and/or identification statements.
Specifically, the FDA is amending the following classification regulations:
Calculator/data processing module for clinical use
Amend the calculator/data processing module for clinical use “identification” description to remove non-device software functions that maintain and retrieve laboratory data
Continuous glucose monitor secondary display
Amend the continuous glucose monitor (CGM) secondary display “identification” description to remove receive and display software functions, and amend the title of the CGM secondary display regulation to “Continuous Glucose Monitor (CGM) Secondary Alarm System”
Automated indirect immunofluorescence microscope and software-assisted system
Amend the automated indirect immunofluorescence microscope and software-assisted system device “identification” description by replacing the first use of the word “software” with “device” because both hardware and software functions that use fluorescent signal acquisition and processing software, data storage, and transferring mechanisms, or assay specific algorithms to interpret or analyze results, are devices
Medical device data systems
Amend the medical device data systems (MDDS) “identification” description to remove non-device software functions intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results
Home uterine activity monitor
Amend the home uterine activity monitor (HUAM) “identification” description to remove non-device software functions intended for transmitting, receiving, and displaying data
Medical image storage device
Amend medical image storage device “identification” description to remove non-device software functions intended for storing and retrieving so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images
Medical image communications device
Amend medical image communications device “identification” description to include software functions intended for medical image processing and manipulation
Picture archiving and communication system
Amend picture archiving and communications system “identification” description to remove non-device software functions intended for storing and displaying medical images, revise the “identification” description to clarify that the regulation includes software and hardware functions intended for medical image management and processing, and revise the title of the classification regulation to “Medical Image Management and Processing System”