Update May 22, 03

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Update May 22, 03

OMBUDSMAN'S ANNUAL REPORT

Calendar Year 2002

If you were not aware, the FDA has an Ombudsman office which investigates complaints from outside the agency and facilitates the resolution of disputes between CDRH and the medical device industry it regulates.

The Ombudsman, Les Weinstein, has been in this position since 2000. He is supposed to maintain his impartiality and neutrality while he works to resolve this disputes.

This Annual Report focuses on statistics about complaints and disputes: the number the Ombudsman received, the CDRH Offices involved, the subjects and reasons, and disposition. You may also wish to see his web site at: http://www.fda.gov/cdrh/ombudsman/

I recommend that you take a look at this website and look at the type of disputes the ombudsman has been involved in, the types of complaints and the resolutions. This can be observed at the following URL - http://www.fda.gov/cdrh/ombudsman/ombudar2002.html

For more information on the FDA Ombudsman contact mdi at info@mdiconsultants.com

.S. AGENT SECTION

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