Working together: FDA releases final guidance on interoperability

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final Guidance). The guidance comes at a time when interoperability of medical systems, particularly in a healthcare institution environment, is increasingly important from safety and cybersecurity standpoints. As companies grapple with proactively addressing interoperability challenges, FDA’s latest guidance serves as one more resource and guidepost for regulated industry. The Final Guidance represents FDA’s current recommendations for the design, development, and marketing of interoperable medical devices (i.e., those devices that share data and information with other devices and systems). The guidance includes recommendations regarding design considerations, risk management and testing, as well as the content of premarket submissions and device labeling. Like the Draft Guidance, the Final Guidance reflects current FDA practice with respect to requests for information for interoperable medical devices, with a particular emphasis on transparency of information pertaining to the performance and interface characteristics of the interoperable device.

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