5/11/2021
Photo by Joshua Sortino on Unsplash
The US Food and Drug Administration (FDA) issued a final rule that changes the classification of some software so that it no longer is regulated as a medical device. The rule was needed to align with updates required by the 21st Century Cures Act (Cures Act). The Cures Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to remove certain software from being classified as a medical device, including software used:
for transfer, displaying, conversion, or storing clinical laboratory test or other device data or results,
for healthy lifestyle tracking that is not related to disease prevention or treatment,
as electronic patient records not used to interpret or analyze them for diagnosis, cure, mitigation, or treatment of a condition, or
for support of healthcare facility administration.
Under the final rule, the following will no longer be regulated as medical devices:
Calculator/Data Processing Modules for Clinical Use
Continuous glucose monitor secondary displays
Automated indirect immunofluorescence microscopes and software-assisted systems
Medical device data systems
Home uterine activity monitors
Medical image storage devices
Medical image communications devices
Picture archiving and communications systems
It is important to remember that medical device hardware classification remains unchanged under the final rule. An additional update of note is that the FDA withdrew the proposed exemptions for certain medical devices from premarket notification as the rationale was flawed and lacked support.
There has been much confusion over which software is considered a medical device. The related guidance document “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” began the changes in classification needed to align with the Cures Act and helped clarify which software was not considered a medical device from a regulatory perspective. The FDA also added a webpage that defines Software as a Medical Device (SaMD) with a link to ask questions on policy.
Another guidance document “Software as a Medical Device (SAMD): Clinical Evaluation” provides the framework for the FDA to develop regulatory oversight for SaMD. You may also enjoy our blog on “FDA Digital Health Center of Excellence & SaMDs”. As use of SaMD continues to grow, the Digital Health Center of Excellence will play a key role in working to advance these technologies and provide information, resources, and regulatory oversight.
-The Clinical Pathways Team
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