FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH 

(CDRH) 

OMBUDSMAN'S ANNUAL REPORT

Calendar Year 2003

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 statistics about complaints and disputes: 

the number 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/20090120120650/http://www.fda.gov/cdrh/ombudsman/. 

I. COMPLAINTS AND DISPUTES

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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B. Source of Complaints and Disputes:

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

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resolution:

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

Office of Device Evaluation (ODE)

Office of Compliance (OC)

Office of Surveillance and Biometrics (OSB)

Office of Health and Industry Programs (OHIP)

(As of June 2004 - Office of Communication, 

Education, and Radiation Programs (OCER)

Office of Systems and Management (OSM)

Office of Science and Technology (OST)

Office of In Vitro Diagnostic Device

Evaluation and Safety (OIVD)

2003

2002 2001

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

2003 2002 2001

510(k)’s 25% 42% 41%

PMA’s 9% 11% 9%

Imports 6% 8% 4%

Competitors/Trade Complaints 6% 2% n/a

IDE’s 4% 11% 4%

513g’s 4% 2% n/a

Adverse Events/MDR 4% 2% n/a

Reuse/Reprocessing 3% 2% 1%

GMP/QSR 3% n/a n/a

Mammography 3% 2% n/a

Registration and Listing 3% n/a n/a

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

reason.)

*Numbers in parentheses indicate rankings in previous years.

G. Status of Complaints and Disputes:

FDA Website 3% n/a n/a

Advertising/Promotion 2% 3% 3%

Recalls 2% 2% 1%

EMS 2% 2% n/a

Disclosure 2% 2% 1%

Lasers 2% n/a n/a

2003 2002* 2001*

1. Miscommunication or lack of communication 22% 16% (2) 15% (4)

2. Lack of timeliness (of approval/clearance; setting up meetings; 

returning phone calls; etc.)

18% 9% (5) 17% (3)

3. Data, testing requirements to support a premarket submission; 

“least burdensome” 

16% 26% (1) 20% (1)

4. Various policies and procedures 13% 12% (4) 18% (2)

5. Level playing field (claims of unequal treatment) 9% 14% (3) 11% (5)

6. Difficult or unhelpful employees 9% 6% (7) 2% (6)

7. Safety concerns/issues 4% n/a n/a

8. Freedom of Information Act (FOIA) 3% 7% (6) 1% (9)

9. Combination products 2% 2% (8) 1% (8)

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

2003*

2002

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

withdrawn or had no follow-up by complainant:

* Includes 120 complaints/disputes received in 2003 and 25 

pending

at the end of 2002 that were carried over to 2003 for a total of 

145.

2001

2003* 2002

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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/20090120120650/http://www.fda.gov/cdrh/resolvingdisputes/1121.pdf.

In 2003 the Ombudsman received one request for review of a scientific dispute by the Medical Devices 

Dispute Resolution Panel, which he granted, but the scheduled meeting of the Panel was subsequently 

postponed indefinitely. In 2002 the Ombudsman did not receive any requests for this Panel to review a 

*Includes complaints /disputes received in 2003 plus those

pending at the end of 2002 that were carried over to 2003.

2001

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scientific dispute. In 2001 he received one such request, which he granted, and the Panel reviewed the 

dispute in September 2001. 

Updated March 31, 2004

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