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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://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:

Complaints = 82 in 2003, 27 in 2002 and 51 in 2001. Disputes = 38 in 2003, 26 in 2002 and 21 in 2001. Total = 120 in 2003, 53 in 2002 and 72 in 2001

B. Source of Complaints and Disputes:

Industry: 2003=78, 2002=85, 2001=92; Consumer: 2003=13, 2002=6, 2001=6; Health Care Provider: 2003=4, 2002=9, 2001=1; Other: 2003=5, 2002=0, 2001=1

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

 
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)
Data for 2003 was: ODE=61%, OC=25%, OSB=3%, OHIP=5%, OST=0%, OSM=2%, OIVD=4%
2003

Data for 2002 was ODE=65%, OC=26%, OSB=4%, OHIP=4%, OSM=2%, OST=0%
2002

Data for 2001 was ODE=65%, OC=27%, OSB=3%, OHIP=3%, OSM=3%, OST=0%
2001

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

Data: As Last resort = 2003 was 31, 2002 was 30, 2001 was 22. Early in the process: 2003 was 69, 2002 was 70, 2001 was 78.

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
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

 

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

  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)

*Numbers in parentheses indicate rankings in previous years.

G. Status of Complaints and Disputes:

2003*
Resolved=26%, Pending at year's end=22%, Referred outside CDRH =12%, Withdrawn or no followup by complainant=40%

* 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.
2002
Resolved 40%, Pending at year's end=24%, Referred outside CDRH 9&, Withdrawn or no follow-up by complainant=27%
2001
Resolved=39%, Pending at year's end=36%, Withdrawn or no follow-up by complainant=13%, Referred outside CDRH=12%

H. Status of Complaints and Disputes excluding those that were referred outside CDRH, withdrawn or had no follow-up by complainant:

2003*
Resolved=54%, Pending at year's end=46%

*Includes complaints /disputes received in 2003 plus those
pending at the end of 2002 that were carried over to 2003.
2002
Resolved=62%, Pending at year's end=38%
2001
Resolved=52%, Pending at year's end=48%

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://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 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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