Design Considerations and Recommendations for Interoperable Medical Devices
This guidance provides manufacturers with design considerations and recommendations for developing interoperable medical devices that can safely and effectively exchange and use information with other medical/non-medical products, systems, or devices. It focuses on the information content exchanged over connections rather than physical compatibility aspects, and applies to various premarket submissions including 510(k), De novo, PMA, PDP, HDE and BLA.
What You Need to Know? 👇
What are the key design considerations for developing interoperable medical devices according to FDA guidance?
Manufacturers should consider six key areas: purpose of electronic interfaces, anticipated users, risk management, verification and validation, labeling requirements, and use of consensus standards. Each consideration should be tailored to the interface technology and intended use environment.
How does FDA define interoperable medical devices in their 2017 guidance?
FDA defines interoperable medical devices as devices that can exchange and use information through electronic interfaces with other medical/non-medical products, systems, or devices. This includes simple data transmission and complex interactions like command and control functions.
What verification and validation testing is required for electronic interfaces in medical devices?
Testing should demonstrate interfaces meet design specifications, perform as intended, handle corrupted data appropriately, operate safely under normal and abnormal conditions, and include fault-tolerant design verification. The extent depends on device risks and interface purpose.
What labeling information must manufacturers include for interoperable medical device interfaces?
Labeling should specify interface purpose, anticipated users, connection specifications, data attributes exchanged, testing summaries, relevant standards used, fault tolerance behavior, limitations, contraindications, warnings, and specific user instructions for safe and effective use.
How should manufacturers conduct risk analysis for interoperable medical devices?
Risk analysis must consider interoperability-related hazards, reasonably foreseeable misuse, security vulnerabilities, fault conditions, and system-level risks. Manufacturers should address how devices handle delays, corrupted data, wrong formats, and unsynchronized data while maintaining basic safety.
What premarket submission documentation does FDA recommend for interoperable medical devices?
Submissions should include detailed device descriptions of electronic interfaces, comprehensive risk analysis addressing interoperability hazards, verification and validation testing results, and appropriate labeling. Documentation level varies based on device risk and interface complexity.
What You Need to Do 👇
Recommended Actions
- Document purpose and specifications of all electronic interfaces
- Conduct comprehensive risk analysis considering interoperability aspects
- Implement appropriate verification and validation testing
- Develop clear labeling for different user types
- Consider using recognized consensus standards
- Implement appropriate security controls
- Document all design decisions and risk mitigations
- Prepare appropriate premarket submission documentation
- Establish post-market surveillance for interoperability issues
- 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
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 ID: 6e58228ef56556143c2b3656df4886bb