Contact Guidelines and Confidentiality
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.
If you contact the Ombudsman you may prefer to keep your identity confidential and may ask to keep your name, the name of your company or even the nature of your complaint confidential. Generally, he can keep this information confidential if you request him to do so. Naturally, a pledge of confidentiality may hinder the Ombudsman from facilitating a resolution to a specific problem. If so, he will explain this to you and not proceed any further to investigate a complaint unless you release him from the pledge. There are a few matters, however, in which confidentiality cannot be preserved, such as allegations of criminal activity, which 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.
David S. Buckles, PhD, FACC
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
E-mail address: CDRHOmbudsman@fda.hhs.gov