The US Food and Drug Administration (FDA) has published a ruling in the Federal Register removing certain software functions from its device classification regulations. Published on April 19 2021, the ruling is effective immediately from this date.
The Federal Food, Drug and Cosmetic Act (FD&C Act) is the set of laws that govern medical devices and as such sets out the software functions of a medical device. However, the 21st Century Cures Act introduced in late 2016 amended the FD&C Act to include descriptions of software functions that are excluded from the definition of a device.
Eight classification regulations have been amended to reflect the FDA’s latest stance on software functions in medical devices. The FDA brings attention to a particular function that has been excluded stating that it is the most pertinent to the ruling; “the software functions intended to transfer, store, convert formats, or display clinical laboratory test or other device data, results, and findings and that do not interpret or analyze such clinical laboratory test or other device data, results, and findings.”
Since this ruling only excludes certain software functions from the definition of a device, the regulatory status of the device hardware is not affected and consequently neither are the classifications for device types.
Essentially, this ruling has been published to ensure that software functions of medical devices conform to the latest changes to the FD&C Act as introduced by the implementation of the 21st Century Cures Act.
To view the ruling in full, click here.