Resolving Disputes Concerning FDA and Medical Devices

By: David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell 

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.

David S. Buckles, PhD, FACC

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. 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. 

Legislation passed last year by Congress introduced the term “significant decision” to our regulatory lexicon and included certain expectations of how we are to deal with disagreements over such decisions. FDA has proposed its interpretation of what constitutes a “significant decision” in a question and answer draft guidance document, entitled, “Center for Devices and Radiological Health Appeals Processes: Questions and Answers about 517A.” This draft guidance is available for public comment. We believe that when it comes to disputes, all stakeholders play an important role in resolution. Therefore, we strongly encourage interested parties to provide comments and suggestions to improve our appeals process to help us meet our goal of providing a fair, equitable, predictable and transparent means for seeking resolution of disputes. 

In our current experience, differences of opinion that arise before a final decision is reached can usually be resolved through discussion, or even, occasionally, mediation. If interactive discussion with a lead reviewer, team leader or Consumer Safety Officer does not move the ball forward, we have found that outreach by the stakeholder to engage Branch and Division management in the discussion usually has a good chance of success. We have never yet had a senior manager turn us down when we’ve asked them to take a look at a situation, and we strongly encourage stakeholders to make a good faith effort to connect with management at least through the Division level before considering more formal approaches. 

Lawrence "Jake" Romanell

When discussion and interaction through the Division level fails to resolve a dispute, stakeholders usually have several options. By far the most common approach is to request internal agency supervisory review as provided in the Code of Federal Regulations, at 21 CFR 10.75. When a request is made for internal agency review of a decision of an FDA employee, the decision is subject to review by the FDA employee’s supervisor. Generally, such a request for internal agency review is filed with the manager at the next organizational level above the level that either signed the document in dispute or was substantively involved in the decision. 

In the past several years FDA’s Center for Devices and Radiological Health has come a long way in standardizing the appeal process and setting consistent expectations, both internally and externally, to ensure that stakeholders with a legitimate dispute receive a fair and impartial hearing by senior management. Our updated guidance documents will make our process even more clear—and clarity helps make for smoother decisions. 

Wasn’t it Gandhi who said that honest disagreement is often a good sign of progress? 

David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell, are in FDA’s Center for Devices and Radiological Health, Office of the Ombudsman

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