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CDRH Ombudsman Issues Annual Report for 2004

Weinstein
Weinstein: Complaints down 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.

For calendar year 2004, the ombudsman reported a total of 125 complaints and disputes, a 4% decrease as compared with 2003. The overwhelming majority of complaints —90%—came from industry, with 7% from consumers, and 3% from healthcare providers.

The CRDH agency most often cited in complaints or disputes was the Office of Device Evaluation at 66%, followed by the Office of Compliance at 22%. The majority of the complainants sought the intervention of the ombudsman early in the process (62%), while more than a third (38%) sought intervention “as a last resort.”

Among the issues brought to the attention of the ombudsman, 28% focused on premarket notifications (510(k)s). Import issues and competitive trade complaints were each cited in 7% of the cases. Premarket approval (PMA) applications, investigational device exemptions (IDEs), and requests for information about the classification of a device and its applicable regulatory requirements each accounted for 6% of complaints. Freedom of information requests were associated with 5% of the cases. All other matters were cited in 4% or less of the complaints.

The most commonly cited complaint (25% of the cases) involved miscommunication or lack of communication, while 16% were concerned with data in support of a submission (‘least burdensome’ issues). Another 14% of the cases involved policies and procedures, and 12% complained about the agency’s lack of timeliness.

In terms of disposition, the ombudsman reported that at year’s end 31% of the cases had been resolved, 35% were still pending, 13% had been referred outside CDRH, and 21% had been withdrawn with no follow-up from the complainant. The ombudsman noted that in 2004 there were no requests from a complainant to have a hearing before the medical device dispute resolution panel.

The ombudsman’s report uses charts and graphs to compare 2004 data with data from the two previous years. The complete report is available via www.fda.gov/cdrh/ombudsman/annual/ombudar2004.html.

© 2005 Canon Communications LLC

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