No more PACS according to new FDA classifications

Image – An Agent-Based Infrastructure for Secure
Medical Imaging System Integration
by Kamran Sartipi

PARCA eNews – April 20, 2021 – The FDA issued a final rule on its Medical Device Classification Regulations to conform with medical software provisions of the 21st Century Cures Act.

That act excluded certain software functions from the definitions of medical devices. In doing so, the FDA reviewed and changed its regulations for eight classifications of medical devices and in the process renamed PAC systems to Medical Image Management and Processing System or MIMPS.

The FDA explained the change in the federal register stating that software functions in the PACS classification regulation for storage and display of medical images no longer fall within the definition of device.

"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."

What the change means:

• Software functions of PACS for transfer, storage, conversion or display of clinical laboratory tests, medical images, or other medical device data and results will no longer be defined as a device.
• Software that interprets or analyzes such data will continue to fall within the definition of a device.
• The rule only amends certain classification regulations to reflect changes made to the Food, Drug and Cosmetic Act by the Cures Act.

The update is effective with Monday's publication of the rule on April 19, 2021.

Source: FDA publication of 21 CFR Parts 862, 866, 880, 884, and 892 as published in the Federal Register