FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, 1/16

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In January, 2016, the CDRH and CBER branches of the FDA published Guidance for Industry and FDA Staff, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. This document is intended to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.

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 include:

• Technology needed 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