Device Interoperability: US FDA Details Expectations In Final Guidance
Electronic interface functionality, data-exchange factors and time synchronization are among key interoperability factors for device-makers to consider in device design and pre-market submissions, US FDA says in a final guidance document. The guidance stresses the need for developers to consider potential risks of interoperability from device conception and throughout the lifecycle.
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Additions To Interoperability Guidance Proposed By FDA Reviewer In Likely Internal Agency Recommendation
An FDA reviewer has proposed two recommendations to FDA's recent interoperability guidance that would require a letter outlining cooperation between manufacturers whose products interact and how to simultaneously submit 510(k) applications for products where changes can affect interoperability of multiple devices. Reviewer Ian Broverman's comments, however, may not have been meant for public consumption and was likely meant to be an internal FDA recommendation.
For manufacturers designing devices intended to be interoperable with other systems, FDA spelled out its premarket expectations for proper risk analyses, verification and validation studies, and suggested labeling in a Jan. 25 draft guidance.