CDRH Ombudsman's Annual Report - Calendar Year 2004

Les Weinstein was appointed as the first CDRH Ombudsman in April 2000. As an external Ombudsman, he looks into complaints from outside the 

agency and facilitates the resolution of disputes between CDRH and the medical device industry it regulates. While providing this service, he 

maintains his impartiality and neutrality. This Annual Report focuses on complaints and disputes: the number of contacts the Ombudsman 

received, their source, the CDRH Offices involved, the subjects, reasons and disposition. You may also wish to see his web site at 

http://web.archive.org/web/20090120120556/http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html. 

I. CONTACTS 

Most contacts the Ombudsman receives are in the form of a complaint or dispute. A complaint is typically an expression of dissatisfaction, perhaps 

about timeliness, lack of communication, or an unhelpful employee. A dispute usually involves a disagreement with, a challenge to or an appeal of 

a decision or action the Center has taken or is about to take. 

A. Number received: 

B. Source of Contacts:

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

U.S. Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Devices and Radiological Health

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C. CDRH Office either mentioned in Complaints, Disputes and other contacts or referred to by the Ombudsman for 

resolution or a response:

Key:

D. When the Ombudsman was contacted, if related to a process such as premarket submission: 

OCD Office of Center Director OC Office of Compliance 

OCER Office of Communication, Education, and Radiation Programs

(Formerly Office of Health and Industry Programs - OHIP) 

ODE Office of Device Evaluation 

OIVD Office of In Vitro Diagnostic Device Evaluation and Safety OMO Office of Management Operations (Formerly Office of 

Systems and Management - OSM) 

OSEL Office of Science and Engineering Laboratories (Formerly 

Office of Science and Technology - OST)

OSB Office of Surveillance and Biometircs (OSB) 

2004 2003 2002

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E. Subject of Complaints, Disputes and other contacts: (Only those 2% of the total or more are listed.)

F. Most common reasons for Complaints and Disputes by rank: (Some involved more than one reason.) 

*The numbers in parentheses indicate rankings in previous years.

2004 2003 2002

510(k) 28% 25% 42% 

Imports 7% 6% 8% 

Competitor/Trade Complaint 7% 6% 2% 

513g 6% 4% 2% 

IDE 6% 4% 11% 

PMA 6% 9% 11% 

FOIA 5% 7% 1% 

Registration & Listing 4% 3% 0% 

Inspection 4% 0% 0% 

Breast Implants 3% 2% 0% 

Exports 3% 1% 2% 

User Fees 2% 1% n/a 

HDE 2% 0% 0% 

Combination Product 2% 2% 1% 

2004 2003* 2002* 

1. Miscommunication or lack of communication 25% 22% (1) 16% (2) 

2. Data, testing requirements to support a submission; “least burdensome” 16% 16% (3) 26% (1) 

3. Various policies and procedures 14% 13% (4) 12% (4) 

4. Lack of timeliness (of approval/clearance; setting up meetings; returning phone 

calls; etc.) 

12% 18% (2) 9% (5) 

5. Level playing field (claim of unequal treatment) 7% 9% (5) 14% (3) 

6. Difficult or unhelpful employee 6% 9% (6) 6% (6) 

7. Claim of conflict of interest, bias or retaliation 2% 2% (10) 1% (9) 

8. Safety concern/issue 2% 4% (7) n/a 

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G. Status of Complaints and Disputes: 

H. Status of Complaints and Disputes excluding those that were referred outside CDRH, withdrawn or had no follow-up 

by complainant: 

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL 

On July 2, 2001 the Guidance for industry and FDA entitled “Resolving Scientific Disputes Concerning the Regulation of Medical Devices: a 

Guide to Use of the Medical Devices Dispute Resolution Panel” was issued in Final. This Guidance is available at 

http://web.archive.org/web/20090120120556/http://www.fda.gov/cdrh/resolvingdisputes/1121.pdf. 

In 2004 the Ombudsman did not receive any requests for review of a scientific dispute by the Medical Devices Dispute Resolution Panel. In 2003 

the Ombudsman received one request, which he granted, but the scheduled meeting of the Panel was subsequently postponed indefinitely. In 2002 

the Ombudsman did not receive any requests. In 2001 he received one request, which he granted, and the Panel reviewed the dispute in September 

2001. 

Updated February 4, 2005

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2004* 2003 2002

*Includes complaints/disputes received in 

2004 plus those pending at the end of 2003 

that were carried over to 2004.

2004* 2003 2002

*Includes complaints/disputes received in 

2004 plus those pending at the end of 2003 

that were carried over to 2004.

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Center for Devices and Radiological Health / CDRH

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