The U.S. Food and Drug Administration (FDA) recently acted to end the use of PACS. Now, the FDA will refer to these devices as medical image management and processing system (MIMPS). The change is explained in the “Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act.”
The FDA states: The Picture Archiving and Communications Systems (PACS) device includes both software and hardware image storage and display functions and software image processing functions (21 CFR 892.2050). FDA has determined that software functions in the PACS classification regulation for storage and display of medical images no longer fall within the definition of a device under section 520(o)(1)(D) of the FD&C Act. However, FDA recognizes that some software functions in the PACS regulation, which are for complex image processing, including those for image manipulation, enhancement, or quantification, remain device functions. Therefore, FDA is amending this regulation to change the title of the classification regulation from “Picture Archiving and Communications Systems” to “Medical Image Management and Processing System” and is amending the “identification” description to exclude software functions for the “storage and display” of medical images. In addition, the amendment to the PACS classification regulation clarifies specific functions and the device’s intended use with examples in the “identification” description.
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