The U.S. Food and Drug Administration (FDA) amended eight classification regulations to reflect recent regulatory changes. Three of those are radiology-specific:
- 2010: Medical Image Storage Device
- 2020: Medical Image Communication Device
- 2050: Picture Archiving and Communications System
In addition to these changes, the FDA amended a regulation to change the title of the classification from “Picture Archiving and Communications Systems” to “Medical Image Management and Processing System.” They also amended the “identification” description to exclude software functions for the “storage and display” of medical images. The rule went into effect on the same day it was published in the Federal Register on April 19.
The agency said since the provision only excludes certain software functions from the device definition, the regulatory status of device hardware will remain unchanged.
The radiology-specific software systems that will no longer be regulated as devices include: medical image storage devices, medical image communication devices and picture archiving and communication systems.
An update for the PACS regulation
The agency said 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.” As such, the FDA amended the identification description to exclude software functions for the storage and display of medical images. They also clarified specific functions and the device’s intended use with examples.
The regulation has also been renamed “Medical Image Management and Processing System.” This name change is supposed to recognize that there are some software functions for complex image processing (such as image manipulation, enhancement, and quantification) in this regulation that remain as device functions.
Why did this happen?
The name change from PACS to MIMPS reflects an update to the definition of PACS as a medical device. The updated definition no longer includes certain software functions, in accordance with the Cures Act. The description of “identification” now excludes software functions for the “storage and display” of medical images.
The Cures Act, which was enacted in December 2016, included provisions that amended the Federal Food, Drug, and Cosmetic (FD&C) Act to remove certain software functions from the definition of a medical device. This change exempted those applications from FDA regulation. The FDA’s amended identification descriptions now fully reflect these exclusions.
Michael Peters, ACR director of legislative and regulatory affairs, also explained to HCB news why this rule came into effect: “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 system. 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.”
What are the impacts of these changes?
Since the FDA’s amendments to certain classification regulations were done to conform to the medical software provisions in the Cures Act, the FDA believes the changes will not impose any additional regulatory burdens.
RapidResults™, RamSoft’s zero-footprint viewer, is an FDA-cleared device. However, now that RapidResults™ is no longer considered a medical device in accordance to the FDA’s amendments, a 510(k) device clearance is no longer required for it.
See the final rule at the Federal Register.