CDRH Ombudsman's Annual Report -

Calendar Year 2006

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/20090513113214/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: 120 

54 Complaints

40 Disputes

26 Other

B. Source of Contacts:

Industry: 78%

Consumers: 9%

Health Care Providers: 3%

Miscellaneous: 10%

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Food and Drug Administration

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

referred to by the Ombudsman for assistance in resolving the issue or responding to the 

contact:

(Some involved more than one office.)

Office of the Center Director (OCD): 4%

Office of Compliance (OC): 21%

Office of Communication, Education and Radiation Programs (OCER): 12% 

(Includes 9% that were referred for assistance to the Division of Small Manufacturers, International and 

Consumer Assistance (DSMICA.)) 

Office of Device Evaluation (ODE): 45%

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD): 4%

Office of Management Operations (OMO): 2%

Office of Science and Engineering Laboratories (OSEL): 2%

Office of Surveillance and Biometrics (OSB): 2%

Other: 8%

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

total are listed.)

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

than one reason.)

510(k) 29% 

IDE/HDE 7% 

PMA 6% 

Advertising/Promotion 5% 

513(g) 4% 

Adverse Event 4% 

Trade Complaint 4% 

Import 3% 

Inspection 3% 

GMP/QSR 3% 

Laser 3% 

Registration & Listing 3% 

Safety Concern/Issue 3% 

Company Whistleblower 3% 

Drug or Device? 2% 

Labeling 2% 

Mammography 2% 

Warning Letter 2% 

FOIA/Disclosure 2% 

Combination Product 2% 

2006 ( Numbers in parentheses indicate rank the previous year.) 

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F. Status of Complaints, Disputes and other contacts, excluding those that were referred 

outside CDRH, withdrawn or had no follow-up by complainant:

Resolved: 81%*

Pending at end of 2006: 19%*

* Includes complaints/disputes, etc. received in 2006 plus those pending from previous years that were 

carried over to 2006.

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. This Guidance is available at 

http://web.archive.org/web/20090513113214/http://www.fda.gov/cdrh/resolvingdisputes/1121.pdf. 

In 2006 the Ombudsman received three requests for review of a scientific dispute by the Medical Devices 

Dispute Resolution Panel. Of these, the Ombudsman granted two and denied one. Of the two he granted, 

the Panel heard one of the disputes at a December 15, 2006 meeting and the other at an April 19, 2007 

meeting.

Updated August 22, 2007

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Center for Devices and Radiological Health / CDRH

1. Miscommunication or lack of communication (1) 

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

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

4. Various policies and procedures (5) 

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

6. Safety concern/issue (4) 

7. Difficult or unhelpful employee (7) 

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