Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
This guidance clarifies the impact of Section 3060 of the 21st Century Cures Act on medical software regulation, specifically focusing on software functions that are excluded from the definition of a medical device under sections 520(o)(1)(A)-(D) of the FD&C Act. It details changes to existing FDA guidance documents related to medical device software.
What You Need to Know? 👇
What software functions are excluded from the medical device definition under the 21st Century Cures Act?
The Cures Act excludes four categories: administrative support software for healthcare facilities, healthy lifestyle software unrelated to disease treatment, electronic patient records meeting specific criteria, and software for transferring/storing/displaying device data without interpretation or analysis.
Do mobile health apps for fitness tracking still require FDA regulation after the Cures Act?
No, mobile apps intended for maintaining healthy lifestyle (like fitness tracking, calorie counting, or sleep monitoring) are not medical devices if they’re unrelated to diagnosis, cure, mitigation, prevention, or treatment of diseases or conditions.
What are the requirements for electronic health record software to be excluded from device regulation?
EHR software must meet three criteria: records created/reviewed by healthcare professionals, certified under ONC Health IT Certification Program, and not intended for interpretation or analysis of patient records for medical purposes.
Are Medical Device Data Systems (MDDS) still regulated as medical devices?
Software functions that only transfer, store, convert formats, or display medical device data are not devices. However, hardware components of MDDS remain devices, though FDA exercises enforcement discretion for compliant systems.
How does the Cures Act affect clinical decision support software regulation?
Clinical decision support software is addressed separately under section 520(o)(1)(E). Software that interprets or analyzes patient data for diagnosis, treatment, prevention, cure, or mitigation remains subject to FDA regulation as medical devices.
What happens to software that has both device and non-device functions after the Cures Act?
Products with multiple functions are addressed under section 520(o)(2). FDA regulates only the device functions while non-device functions remain unregulated. The agency provides separate guidance for these multi-function products.
What You Need to Do 👇
Recommended Actions
- Review existing software products to determine if they fall under the excluded categories
- For electronic health record software, verify ONC Health IT Certification status
- Evaluate multiple function products to identify which functions remain regulated as devices
- Update product documentation and regulatory strategy based on new device/non-device status
- For hardware products, maintain compliance with device requirements even if associated software is excluded
- Review labeling to ensure alignment with new regulatory status
- Monitor for additional FDA guidance on clinical decision support software and multiple function products
- Consider implementing version control to track regulated vs non-regulated software functions
Key Considerations
Software
- Software functions for administrative support of healthcare facilities are not devices
- Software functions for maintaining/encouraging healthy lifestyle unrelated to diagnosis/treatment are not devices
- Electronic patient record software functions are not devices if:
- Created/stored/reviewed by healthcare professionals
- Certified under ONC Health IT Certification Program
- Not intended for interpretation/analysis
- Software functions for transferring/storing/converting/displaying clinical data are not devices unless intended for interpretation/analysis
Other considerations
- Hardware products remain devices even when associated software functions are excluded
- Multiple function products containing both device and non-device functions will be addressed separately
- General-purpose IT infrastructure for data transfer/storage/conversion/display is not considered a device
Relevant Guidances 🔗
- Content of Premarket Submissions for Device Software Functions
- Clinical Decision Support Software Functions: Device vs Non-Device Classification
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Policy for Device Software Functions and Mobile Medical Applications
Related references and norms 📂
- 21 CFR 880.6310: Medical Device Data Systems
- 21 CFR 892.2010: Medical Image Storage Devices
- 21 CFR 892.2020: Medical Image Communications Devices