The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software systems from the definition of a device under section 201(h) of the FD&C Act.1
The software systems that have been excluded from the definition of a device and subsequently from regulations that would apply to a medical device are:1
- Software systems used for administrative services within a healthcare facility such as billing, claim processes, managing appointment schedules, business analytics, etc.
- Software used for maintaining or encouraging a healthy lifestyle and which is not intended to cure, diagnose, mitigate, prevent or treat a disease or medical condition.
- Software that is used to store electronic records of the patient which includes patient-provided information.
- Software systems that are used for transferring, storing, converting file formats, or displaying clinical laboratory test data or findings for a health care practitioner, as long as the software is not intended to interpret or analyze test lab or other test results.
This amendment that excludes the above-mentioned software systems from being a device has caused the following guidance documents to be modified to reflect this change:1
- General Wellness: Policy for Low-Risk Devices
- Mobile Medical Applications
- Off-The-Shelf Software Use in Medical Devices
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.
And the following guidance document was obsoleted since it is no longer required:1
- Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
I am sure that this change comes as a relief for most software developers since they now do not have to comply with the FDA requirements of a medical device. If you have more questions or need more information on how this change may impact your product, call us today at 248-987-4497 or email us at firstname.lastname@example.org
1FDA (2019) Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act retrieved on 04/18/2021 from https://www.fda.gov/media/109622/download