In response to changes mandated by the 21st Century Cures Act to the legal definition of “device,” the U.S. Food and Drug Administration has amended some of its classification regulations to exclude certain software functions.
“With this final rule, FDA is amending the ‘identification’ description of eight classification regulations so that the regulations no longer include software functions that the Cures Act excluded from the device definition in the [Federal Food, Drug and Cosmetic] Act,” noted the final rule, which was published in the Federal Register on Monday.
WHY IT MATTERS
Among other major changes, section 3060 of the Cures Act amended the FDA’s authority to regulate some medical software.
The Cures Act-amended FD&C Act excludes from the definition of “device” software functions intended for:
- Healthcare facility administrative support
- Healthy lifestyle maintenance (unrelated to disease prevention or treatment)
- Serving as electronic patient records, so long as the function is not intended to interpret or analyze them for the purpose of condition diagnosis, cure, mitigation or treatment
- Transferring, storing, converting formats or displaying clinical laboratory test or other device data or results
“Because the provision only excludes certain software functions from the device definition, the regulatory status of device hardware remains unchanged,” noted the rule.
The eight updated classification regulations include those concerning calculator/data processing modules for clinical use; medical device data systems; medical image storage devices; and medical image communications devices; as well as continuous glucose monitor secondary displays; automated indirect immunofluorescence microscope and software-assisted systems; Picture Archiving and Communications Systems; and home uterine activity monitors.
The FDA makes an exclusion for software functions if they are reasonably likely to have serious adverse health consequences. In addition, devices with multiple functions may contain excluded software.
The rule follows a document posted on the Federal Register this past week by the FDA and the U.S. Department of Health and Human Services that withdrew a proposal by the Trump administration to exempt 84 medical devices from premarket review.
“Upon review, HHS and FDA have determined that the proposed exemptions in the January 15, 2021, Notice were published without adequate scientific support, that the Notice contained errors and ambiguities, and that the Notice is otherwise flawed, as described below,” wrote acting FDA Commissioner Janet Woodcock and HHS Secretary Xavier Becerra in the document.
THE LARGER TREND
The provisions in the Cures Act concerning software and the FDA had caused confusion following the law’s passage, with health IT groups asking the agency to make it clear how it would regulate applications it still considers devices.
Much of that confusion focused on clinical decision support software; the FDA has released several guidance documents over the years intending to provide clarity on which products are still subject to enforcement.
ON THE RECORD
“In this action, FDA is amending eight classification regulations so that the regulations conform to the medical software provisions of the Cures Act and reflect FDA’s current statutory authority,” explained the agency.