Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
This guidance clarifies FDA's regulatory approach to Medical Device Data Systems (MDDS), medical image storage devices, and medical image communications devices. It distinguishes between software functions (Non-Device-MDDS) and hardware functions (Device-MDDS) that transfer, store, convert formats, or display medical device data and results.
What You Need to Know? 👇
What is the difference between Non-Device-MDDS and Device-MDDS under FDA regulations?
Non-Device-MDDS are software functions that transfer, store, convert formats, or display medical device data and are not considered devices under the FD&C Act. Device-MDDS are hardware functions performing the same tasks but remain devices, though FDA doesn’t enforce regulatory requirements for them.
Does FDA require premarket approval for medical device data systems?
No, FDA does not intend to enforce regulatory controls including premarket review for both Non-Device-MDDS and Device-MDDS. MDDS were down-classified from Class III to Class I in 2011, and FDA considers them low-risk devices that support digital health advancement.
Are medical image storage and communications devices subject to FDA enforcement?
FDA does not intend to enforce compliance with regulatory controls for medical image storage devices and medical image communications devices due to their low risk to patients and importance in advancing digital health interoperability.
What software functions are excluded from being medical devices under the 21st Century Cures Act?
Software functions solely intended to transfer, store, convert formats, or display medical device data are excluded from the device definition, unless they interpret or analyze clinical laboratory test or other device data, results, and findings.
Can MDDS software generate alarms or alerts without being considered a medical device?
No, software functions that generate alarms, alerts, or prioritize patient information for active monitoring are considered device software functions because they involve analysis or interpretation of device data and results, not just transfer or display.
How does FDA regulate multiple function products containing MDDS functions?
FDA doesn’t regulate Non-Device-MDDS functions in multiple function products. For Device-MDDS functions, FDA doesn’t intend to enforce requirements but may assess their impact on the safety and effectiveness of other device functions within the product.
What You Need to Do 👇
Recommended Actions
- Determine if your software/hardware functions qualify as Non-Device-MDDS or Device-MDDS
- Ensure software functions do not include analysis, interpretation, or control of medical devices
- For Device-MDDS hardware, document that functions are limited to transfer, storage, conversion, or display
- For multiple function products, assess the impact of MDDS functions on device functions
- Verify that any active patient monitoring features are properly classified as device functions
- Document that specialized medical displays are not considered under MDDS scope
- Maintain documentation of MDDS classification decision and rationale
Key Considerations
Software
- Software functions solely intended to transfer, store, convert formats, or display medical device data are not considered devices (Non-Device-MDDS)
- Software must not modify data, control functions of connected medical devices, or analyze/interpret data
- Software generating alarms/alerts or prioritizing patient information are considered device software functions
- Active patient monitoring software requires timely response and is considered a device function
Safety
- Hardware functions must not modify data or control functions of connected medical devices
- Impact of MDDS functions on device functions in multiple function products must be assessed for safety and effectiveness
Other considerations
- FDA does not intend to enforce regulatory controls for hardware functions that are Device-MDDS
- General-purpose IT infrastructure for data transfer, storage, conversion, and display are not considered devices
- Specialized medical display hardware (e.g., for mammography, radiology) are not considered MDDS
Relevant Guidances 🔗
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Content of Premarket Submissions for Device Software Functions
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- 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
- 21 CFR 880.9: Limitations of exemptions
- 21 CFR 892.9: Limitations of exemptions
Original guidance
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- HTML / PDF
- Issue date: 2022-09-28
- Last changed date: 2022-09-27
- Status: FINAL
- Official FDA topics: Medical Devices, Digital Health, Biologics
- ReguVirta ID: 31473b3764da86c38438939c1dc7ab09