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CDRH Ombudsman Graphic of 3 persons holding hands in a circle representing the relationship of the Ombudsman to CDRH and Industry
 

CDRH Ombudsman's Annual Report - Calendar Year 2004

 

 

CDRH Logo

U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

 

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://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:

2004: Complaints = 77, Disputes = 39, Other = 9; 2003: Complaints = 82, Disputes=38; 2002 Complaints=27, Disputes=26

B. Source of Contacts:

2004: Industry 90%, Consumer 7%, Health Care Provider 3%. 2003: Industry 78%, Consumer 13%, Health Care Provider 4%, Other 5%; 2002: Industry 85%, Consumer 6%, Health Care Provider 9%, Other 0%

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

Key:

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)
ODE 66%, OC 22%, OCD 1%, OMO 4%, OIVD 5%, OCER 1%
ODE 61%, OC 25%, OSB 3%, OHIP 5%, OSM 2%, OIVD 4%
ODE 65%, OC 26%, OSB 4%, OHIP 4%, OSM 2%

2004

2003

2002

 

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

2004: As Last Resort=38%, Early in the process=62%; 2003: As Last Resport=31%, Early in the process=69%; 2002 As Last Resport=30%, Early in the process=70%

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

 

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%

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

 

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

*The numbers in parentheses indicate rankings in previous years.

G. Status of Complaints and Disputes:

31% resolved, 35% pending at year's end, 21% withdrawn or no follow-up by complainant, 13% referred outside CDRH
26% resolved, 22% pending at year's end, 40% withdrawn or no follow-up by complainant, 12% referred outside CDRH
40% resolved, 24% pending at year's end, 27% withdrawn or no follow-up by complainant, 9% referred outside CDRH

2004*

2003

2002
*Includes complaints/disputes received in 2004 plus those pending at the end of 2003 that were carried over to 2004.    

 

H. Status of Complaints and Disputes excluding those that were referred outside CDRH, withdrawn or had no follow-up by complainant:

35% pending at year's end and 65% resolved
46% pending at year's end and 54% resolved
38% pending at year's end and 62% resolved

2004*

2003

2002
*Includes complaints/disputes received in 2004 plus those pending at the end of 2003 that were carried over to 2004.    

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 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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