The FDA today issued a ruling that amends medical device classification regulations related to the 21st Century Cures Act.
In an unpublished ruling (it will officially be published on Monday, April 19, 2021), the FDA stated that it took this action to ensure that its regulations conform to the medical software provisions in the Cures Act.
In December 2016, then-President Barack Obama signed the 21st Century Cures Act, which included some provisions intended to improve the regulatory process for medical devices.
Among the provisions was a clarification on the FDA’s role in regulating medical software. Previously, the FDA had regulated image analysis software and IVD technology — and continued to do so after Obama signed the 21st Century Cures Act. However, under the law’s provision, the FDA can not regulate software that uses “big data” to provide clinical decision support to healthcare professionals.
The section has a few exceptions for software that collects patient information and data if it “would be reasonably likely to have serious adverse health consequences.”
In the FDA’s ruling, it amended eight classification regulations to ensure that the regulations conform to the provisions of the Cures Act and reflect the FDA’s current statutory authority.
Additionally, the administration amended the “identification” description of those eight classification regulations so that those regulations no longer include software functions that are excluded from the device definition in the Cures Act.
Here are the eight classifications being amended by the FDA:
- The calculator/data processing module for clinical use “identification” description, removing non-device software functions that maintain and retrieve laboratory data.
- The continuous glucose monitor (CGM) secondary display “identification” description, removing receive and display software functions and amending the title to “CGM secondary alarm system.”
- The automated indirect immunofluorescence microscope and software-assisted system device “identification” description, replacing the first use of the word “software” with “device.”
- The medical device data systems “identification” description, removing non-device software functions for transferring, storing, converting formats or displaying laboratory test or other device data and results.
- The home uterine activity monitor “identification” description, removing non-device software functions for transmitting, receiving and displaying data.
- The medical image storage device “identification” description, removing non-device software functions intended for storing and retrieving.
- The medical image communications device “identification” description, including software functions intended for medical image processing and manipulation.
- The picture archiving and communications system “identification” description, removing non-device software functions intended for storing and displaying medical images. FDA also revised the description to clarify that regulation includes software and hardware functions for medical device image management and processing, as the title was revised to “Medical Image Management and Processing System.”
The final rule from the FDA does not change the classification of the device types for which the FDA is amending the title or “identification” descriptions. The FDA said the rule will ensure conformity to changes under the Cures Act and reflect its statutory authority.