In a final rule published April 19 in the Federal Register, the Food & Drug Administration (FDA) amended various medical device regulations so that the rules would conform to the medical software provisions of the 21st Century Cures Act. Updated are eight FDA "classification" regulations revised to exclude software functions that no longer fall within the device definition of the Federal Food, Drug, and Cosmetic Act.
Among the revised classification regulations, the FDA acted to:
- 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;
- amend medical image communications device “identification” description to include software functions intended for medical image processing and manipulation; and
- amend picture archiving and communications system (PACS) “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” (MIMPS).
The FDA stated that the final rule does not change the classification of the device types for which the title or identification statements were amended. The new rules became effective upon publication.