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.
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 summary file ID: 31473b3764da86c38438939c1dc7ab09
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