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. The Ombudsman can answer questions, follow up on a complaint, discuss appeal and dispute resolution options, or mediate a dispute. While providing this assistance, they maintain impartiality and neutrality. The Ombudsman advises the Center Director, to whom they report, on ways to assure that our procedures, policies and decisions are of the highest quality and are fair and equitable.
Complaints and Disputes: The Ombudsman will do his best to respond to your complaints in a timely and effective manner. Although you may contact the Ombudsman at any time, before contacting him, if possible you should first try to resolve a problem by going up the supervisory chain. For example, if you are having problems with a matter involving one of the Divisions in CDRH, we suggest that you discuss it with the Director of that Division. If you are not satisfied with the outcome of that discussion, you may take the matter to either the Director of the Office to which the Division reports or to the Ombudsman. The Ombudsman does not get involved in matters currently in litigation.
General Comments and Suggestions: The Ombudsman is interested in hearing from you about the effectiveness of our programs and about problems that may be getting in the way of our carrying out our regulatory responsibilities. We welcome such input because it helps us to continually assess the work that we do and improve the way that we do it.
When contacting the Ombudsman you may request to keep your identity, the name of your company, and the nature of your complaint confidential. The Ombudsman will hold the requested information confidential to the extent the law allows. However, there are a few matters in which confidentiality cannot be preserved. For example, allegations of criminal activity must be reported to the FDA Office of Criminal Investigations. Even in these matters, though, the identity of a confidential source may be protected from disclosure to the public.
Abiy B. Desta, Ombudsman
Ken Skodacek, Deputy Ombudsman
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
WO32 Room 4282
10903 New Hampshire Avenue
Silver Spring, MD 20993
E-mail address: CDRHOmbudsman@fda.hhs.gov