CDRH Ombudsman Issues Annual Report for 2004

CDRH Ombudsman Issues Annual Report for 2004

Les Weinstein, ombudsman for FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD), recently released his annual report for calendar year 2004. The office of the ombudsman was established in April 2000 “to investigate complaints from outside the agency and to facilitate the resolution of disputes between CDRH and the medical device industry it regulates.” As he conducts his investigations, the ombudsman is pledged to remain neutral and impartial. The annual report focuses on the number of complaints and disputes, their source, subject matter, reasons, the particular CDRH agency involved, and disposition.