Some Software Functions Exempted from Device Definition

Federal Register final rule: FDA is amending medical device classification regulations to exclude certain software functions from the definition of a device as mandated by the 21st Century Cures Act’s medical software provisions. The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act. Among the software functions excluded from the definition of a device by this provision are those 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. Because the provision only excludes certain software functions from the device definition, the regulatory status of device hardware remains unchanged. To view the notice, click here.