Resolving disputes concerning FDA and medical devices

July 17, 2013 by MassDevice staff

FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.

By David S. Buckles, PhD, FACC, and Lawrence "Jake" Romanell 

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Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA's medical devices center occasionally confronts scientific and policy disagreements among our staff and with the various stakeholders we strive to serve.

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

As Ombudsmen for 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.

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Since 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 inevitably of disputes, what we find important is how we deal with those disagreements. 

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