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.
Center for Devices and Radiological Health
Food and Drug Administration
WO32 Room 4282
10903 New Hampshire AvenueSilver Spring, MD 20993