The U.S. Food & Drug Administration has adjusted the descriptions for three radiology software functions to more accurately align with recent regulatory changes, the organization announced Monday.
The final rule, published April 19 in the Federal Register, outlines software functions that were previously classified as medical devices under the 21st Century Cures Act. Overall, it includes changes to eight software functions.
“In other words, in this action, 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 federal oversight group explained.
Radiologists should take note of three specific modifications.
Medical Image Storage Devices
Because medical image storage includes software functions that are now excluded from device designation status, the FDA has updated its regulation to note that only hardware that performs electronic storage and retrieval functions are now subject to FDA regulation.
Medical image storage devices, as outlined by the FDA, may include electronic hardware devices that use magnetic and optical discs, magnetic tapes, and digital memory.
Picture Archiving and Communication Systems
Perhaps most important is the FDA’s decision that software functions in the PACS classification regulation no longer fall within the definition of a medical device. To reflect this change, the FDA is renaming the regulation to “Medical Image Management and Processing System” or MIMPS.
The description now excludes software functions for the “storage and display” of medical images, according to the FDA. And the software components may provide “advanced or complex image processing functions for image manipulation enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.”
Medical Image Communications Devices
The FDA said it has amended its description to specifically include software functions for medical image processing and manipulation, which have always been included in the regulation.
The description now used to identify these devices has been updated to include the following language:
“It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.”
All changes are effective immediately. Read the entire final rule here.