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Additions To Interoperability Guidance Proposed By FDA Reviewer In Likely Internal Agency Recommendation

This article was originally published in The Gray Sheet

Executive Summary

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.

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