Design Considerations and Recommendations for Interoperable Medical Devices

Recommended Actions

1. Document purpose and specifications of all electronic interfaces
2. Conduct comprehensive risk analysis considering interoperability aspects
3. Implement appropriate verification and validation testing
4. Develop clear labeling for different user types
5. Consider using recognized consensus standards
6. Implement appropriate security controls
7. Document all design decisions and risk mitigations
8. Prepare appropriate premarket submission documentation
9. Establish post-market surveillance for interoperability issues
10. Maintain documentation throughout device lifecycle

Key Considerations

Non-clinical testing

• Verify and validate that data corruption can be detected and managed
• Test device operation when receiving out-of-bounds data
• Implement and verify fault-tolerant design
• Establish and specify fail-safe states for critical functions
• Verify conformance to consensus standards if applicable
• Validate that only authorized users can exchange information
• Test simulated real-world use scenarios

Human Factors

• Validate the user interface for different types of users (clinicians, IT staff, engineers, etc.)
• Consider different user needs when designing device instructions
• Validate labeling regarding electronic interface use

Software

• Specify Application Programming Interface (API) if device software can be used by other software
• Verify software updates and maintenance processes
• Consider time synchronization requirements

Cybersecurity

• Implement appropriate security features in design
• Analyze risks from both intended and unintended access
• Balance allowing intended access while restricting unintended access
• Verify only authorized users can exchange information

Labelling

• Include functional and performance requirements of electronic interfaces
• Specify intended connections and limitations
• Provide instructions for different user types
• Include warnings, precautions and contraindications
• Specify data attributes being exchanged
• Document testing performed and verification steps
• Include recommended settings and configurations

Safety

• Maintain basic safety during normal and fault conditions
• Establish fail-safe states for critical functions
• Implement fault-tolerant design
• Consider safety impacts on connected devices

Other considerations

• Define purpose of electronic interface
• Identify anticipated users
• Consider interoperability scenarios
• Use standardized architectures and protocols when possible
• Specify data format and transmission methods
• Consider system-level impacts

  Relevant Guidances

• Content of Premarket Submissions for Device Software Functions
• Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
• Software Validation for Medical Device Production, Quality Systems, and Device Components

Related references and norms

• IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance
• ISO 14971:2007: Medical devices - Application of risk management to medical devices
• ASTM 2761-09(2013): Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)
• RFC 1305/5905: Network Time Protocol

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Original guidance

• Design Considerations and Recommendations for Interoperable Medical Devices
• HTML / PDF
• Issue date: 2017-09-06
• Last changed date: 2019-02-19
• Status: FINAL
• Official FDA topics: Radiation-Emitting Products, Medical Devices, Cardiovascular, Digital Health, Anesthesiology, 510(k), General Hospital & Personal Use, Biologics, Radiological Health, Dental, Neurological
• ReguVirta summary file ID: 6e58228ef56556143c2b3656df4886bb