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 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.
CDRH Deputy Ombudsman
Lawrence “Jake” Romanell is the Deputy Ombudsman for the Center for Devices and Radiological Health (CDRH). He was previously the Network Leader for the Regulatory Affairs and Special Interests Network in CDRH, where his duties included coordinating the Center’s responses to regulatory issues affecting all types of devices. Prior to becoming a Network Leader, Mr. Romanell was a member of the Program Operations 510(k) Staff where he served as the 513(g) (Requests for Information) coordinator and the RFD (Requests for Designation) coordinator for CDRH. He is a CDRH Staff College instructor for New Scientific Reviewers. Mr. Romanell began his FDA career as a microbiologist and performed scientific reviews for the Division of Ophthalmic and Ear, Nose and Throat Devices. Prior to his employment with the agency, Mr. Romanell served 14 years as the assistant supervisor of the clinical microbiology laboratory at D.C. General Hospital in Washington D.C.