par John R. Fischer
, Senior Reporter | April 23, 2021
The FDA has changed its regulatory classification of PACS (Picture Archiving and Communication Systems), referring to it now as MIMPS (medical image management and processing systems) as part of amended regulatory classification changes made for radiology-specific software.
The name change reflects an update to the definition of PACS as a medical device, which no longer includes certain software functions, in accordance with the Cures Act. These exclusions exempt these applications from FDA review.
“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," said the agency as part of the Final Rule.
Enacted in December 2016, the Cures Act amends the Federal Food, Drug, and Cosmetic (FD&C) Act to remove software functions solely intended to transfer, store, convert formats or display, with few exceptions, according to the FDA.
Functions excluded from the PACS classification regulation include those intended for information transfer, such as data retrieval, receipt or transmission, as well as for storage, such as data maintenance.
"This rule addresses housekeeping items remaining from modifications to FDA oversight in 2016. Specifically, it further differentiates unregulated software functions, such as storage, from regulated software functions, such as complex image processing and manipulation, within products such as PACS. Generally, we do not anticipate a meaningful impact for consumers beyond some additional clarity about what software functions FDA is looking at within these products," ACR director of legislative and regulatory affairs Michael Peters told HCB News.
In addition, the agency has updated its definition of medical image storage software to exclude storage and retrieval capabilities and specifies that only hardware that performs these functions fall under its purview. Among these solutions are electronic hardware devices that use magnetic and optical discs, magnetic tapes and digital memory.
The definition of medical image communication device descriptions has also been altered to include processing and manipulation functions. This may include a physical communications medium, modems and interfaces; simple image review functions, medical image processing and manipulation, including greyscale window and level, zoom and pan, user delineated geometric measurements, compression, or user-added image annotations.
The amendments reflect the state of the law and are not expected by the FDA to impose any additional regulatory burdens.
The final rule was published in the Federal Register
. It is set to take effect immediately, without a comment period.