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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.

Surprisingly, a recent interoperability draft guidance published by FDA has not received any comments from big industry players yet, according to the government's docket system – but it did get two key recommendations from an FDA reviewer. (See [A#01160201002].)

Ian Broverman, an FDA reviewer with CDRH's Office of Device Evaluation, wrote to his own agency asking for the draft interoperability guidance to include a section requiring manufacturers...

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