Center for Devices and Radiological Health, U.S. Food and Drug Administration

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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 2005

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:

Bar graph. 2005, 72 complaints, 25 disputes, 17 other, for a total of 114. 2004, 77 complaints, 39 disputes, 9 other, for a total of 125. 2003, 82 complaints, 38 disputes, 0 other, for a total of 120.

B. Source of Contacts:

Bar graph. 2005, 75% industry, 17% consumer, 4% health care provider, 5% other. 2004, 90% industry, 7% consumer, 3% health care provider, 0% other. 2003, 78% industry, 13% consumer, 4% health care provider, 5% other.

C. CDRH Office mentioned in Complaints, Disputes and other contacts; or CDRH Office asked by the Ombudsman for resolution or response:

Key:

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

Pie chart for 2005. ODE, 52%. OCER, 5%. OC, 22%. OIVD, 4%. OSEL, 2%. OSB, 5%. OCD, 2%. Other, 9%. Pie chart for 2004. ODE, 66%. OCER, 1%. OC, 22%. OIVD, 5%. OMO, 4%. OCD, 1%. OSEL and OSB, 0%.
Pie chart for 2003. ODE, 61%. OC, 25%. OSB, 3%. OCER, 5%. OIVD, 4%. OMO, 2%. OCD and OSEL, 0%.

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

	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%
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

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

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

F. Status of Complaints and Disputes:

Pie chart for 2005. Pending at year's end, 41%. Resolved, 33%. Referred outside CDRH, 4%. Withdrawn or no follow-up by complainant, 22%.
* Includes complaints/disputes received in 2005 plus those pending from previous years that were carried over to 2005.

Pie chart for 2004. Pending at year's end, 35%. Resolved, 31%. Referred outside CDRH, 13%. Withdrawn or no follow-up by complainant, 21%.

Pie chart for 2003. Pending at year's end, 22%. Resolved, 26%. Referred outside CDRH, 12%. Withdrawn or no follow-up by complainant, 40%.

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.

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 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

horizonal rule

Center for Devices and Radiological Health / CDRH