CDRH Ombudsman's Annual Report -

Calendar Year 2005

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/20090120120624/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: 

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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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B. Source of Contacts:

C. CDRH Office mentioned in Complaints, Disputes and other contacts; or CDRH Office 

asked by the Ombudsman for resolution or response: 

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Key:

D. Subject of Complaints, Disputes, and other contacts: (Only those 2% of the total or 

more are listed.)

OCD Office of Center Director OC Office of Compliance 

OCER Office of Communication, Education, and Radiation 

Programs

ODE Office of Device Evaluation 

OIVD Office of In Vitro Diagnostic Device Evaluation and 

Safety 

OMO Office of Management Operations

OSEL Office of Science and Engineering Laboratories OSB Office of Surveillance and 

Biometircs

2005 2004 2003 

510(k) 16% 28% 25% 

Adverse Event/MDR/Device Malfunction 9% N/A N/A 

Imports 8% 7% 6% 

PMA 7% 6% 9% 

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E. Most common reasons for Complaints and Disputes by rank: (Some involved more 

than one reason.)

F. Status of Complaints and Disputes:

* Includes complaints/disputes received in 2005 plus those pending from previous years that were carried 

IDE 6% 6% 4% 

513g 5% 6% 4% 

Disclosure 4% N/A N/A 

Trade Complaint 4% 7% 6% 

Data Integrity 3% N/A N/A 

Exports 3% 3% 1% 

SUD/Re-use/Reprocessing 3% N/A N/A 

Whistle Blower 3% N/A N/A 

Combination Product 3% 2% 2% 

Laser 3% N/A N/A 

Mammography 2% N/A N/A 

Pre-IDE 2% N/A N/A 

Promotion 2% N/A N/A 

Software 2% N/A N/A 

2005 2004 2003 

1. Miscommunication or lack of communication 1 1 

2. Data, testing requirements to support a submission; “least burdensome” 2 3 

3. Lack of timeliness (of approval/clearance; setting up meetings; returning phone calls; etc.) 4 2 

4. Safety concern/issue 8 7 

5.Various policies and procedures 3 4 

6. Level playing field (claim of unequal treatment) 5 5 

7. Difficult or unhelpful employee 6 6 

8. Freedom of Information Act (FOIA) N/A N/A 

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over to 2005.

G. Status of Complaints and Disputes excluding those that were referred outside CDRH, 

withdrawn or had no follow-up by complainant:

* Includes complaints/disputes received in 2005 plus those pending from previous years that were carried 

over to 2005.

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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/20090120120624/http://www.fda.gov/cdrh/resolvingdisputes/1121.pdf. 

In 2005 and 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. 

Updated June 7, 2006

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Center for Devices and Radiological Health / CDRH

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