Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders it strives to serve.

Disputes can occur at any stage of a particular interaction, from an initial inquiry or presubmission review to a final regulatory decision on an application or submission.

As ombudsmen for the FDA’s medical devices center, our office investigates complaints from outside the FDA and facilitates the resolution of disputes between FDA’s medical devices center and the industry we regulate. Because part of our job is maintaining impartiality and neutrality, we are a good starting point if you have a complaint, question, or dispute of a scientific, regulatory, or procedural nature. Given the inevitability of disputes, what we find important is how we deal with those disagreements.

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