If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just published by the FDA. This document contains recommendations intended to promote the safe and effective exchange of information between devices. Make sure you and your team are aware of these best practices, so you can incorporate them into your medical device.
What’s in this draft guidance document?
Within this guidance, “interoperability” is defined as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.
Design Considerations
These specific development and design considerations should be taken into account:
- Technology to support the purpose for the data interface (e.g., send-only, receive-only, control)
- The expertise and limitations of expected users
- Risk identification, assessment, and mitigation
- Validation and verification to ensure that the devise is working correctly before delivery and continues to work in real use
- Labeling to ensure safe, predictable use
Download the FDA draft guidance here: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Do you need more help implementing these recommendations within your organization? Talk to our CSV experts to see how they can help.