CDRH Ombudsman

The CDRH Ombudsman investigates complaints from outside FDA and facilitates the resolution of disputes between CDRH and the industry it regulates. The CDRH Ombudsman is a good starting point if you have a complaint, question, or dispute of a scientific, regulatory, or procedural nature. He can answer questions, follow up on a complaint, discuss appeal and dispute resolution options, or mediate a dispute. While providing this assistance, he maintains his impartiality and neutrality. The Ombudsman advises the Center Director, to whom he reports, on ways to assure that our procedures, policies and decisions are of the highest quality and are fair and equitable.

Dr. David S. Buckles is currently serving as the Ombudsman for the Center for Devices and Radiological Health, FDA. He has been with FDA in various capacities since 2003, including Reviewer and Branch Chief in the Office of Device Evaluation, and Branch Chief and Division Director in the Office of Surveillance and Biometrics. Prior to joining FDA, Dr. Buckles was in the cardiovascular medical device industry for several years as Chief Scientist and Chief Technology Officer, serving also in regulatory affairs and quality assurance roles. From 1985 to 1995 Dr. Buckles was a researcher, faculty member and health care provider at the Children’s Hospital, Medical University of South Carolina (MUSC), working in the field of congenital heart disease. He is a Fellow of the American College of Cardiology and a member of the Heart Rhythm Society. He received a BS in chemistry from the University of Texas at Austin and a PhD in biomedical systems science from MUSC.