Les Weinstein was appointed as the first CDRH Ombudsman in 2000. As a primarily 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, disputes, 

and inquiries: the number of contacts the Ombudsman received, their source, the CDRH offices

involved, the subjects, reasons and disposition.

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. An 

inquiry may be a question or an issue that does not rise to the level of a complaint or a dispute.

A. Total Number Received – 250:

Complaints: 53%

Disputes: 21%

Inquiries: 26%

B. Source of Contacts:

Industry: 70%

Consumers: 17%

Health Care Providers: 9%

Misc: 4%

C. CDRH Office mentioned in Complaints, Disputes, and Inquiries; or Office referred to by 

the Ombudsman for assistance in resolution or response: (Some may include more than

one Office.)

Office of the Center Director (OCD): 6%

Office of Communication, Education, and Radiation Programs (OCER): 6%

Office of Compliance (OC): 17%

CDRH Ombudsman Annual Report - Calendar Year 2009

U.S. Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Devices and Radiological Health

I. CONTACTS

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Office of Device Evaluation (ODE): 54%

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

Office of Management Operations (OMO): 9%

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

Office of Surveillance and Biometrics (OSB): 4%

D.Subject of Complaints, Disputes, and Inquiries: (Only those above 1% of the total are

listed.)

510(k): 15%

PMA/IDE/HDE: 9%

FOIA/Disclosure: 8%

Trade Complaint: 7%

Registration & Listing: 5%

Pre-IDE: 5%

De Novo: 5%

Adverse Event/MDR/Safety: 4%

Combination Product: 3%

Inspection: 3%

Post-Market Study: 3%

Imports: 3%

E. Most Common Reasons for Complaints, Disputes, and Inquiries by rank:

1. Various policies and procedures

2. Data/testing requirements to support a submission; not “least burdensome”

3. Miscommunication or lack of communication

4. Lack of timeliness (of approval/clearance; scheduling meetings; returning phone calls, etc.)

5. Level playing field (claim of unequal treatment)

6. Complaints about specific CDRH employees

F. Year-end Status of Complaints, Disputes, and Inquiries, excluding those that were 

referred outside CDRH, withdrawn, or had no follow-up by the initiator:

Closed (Complaint addressed, dispute resolved, or inquiry responded to): 92%

Pending: 8%

In 2009, the Ombudsman received one request for review of a scientific dispute by the Medical

Devices Dispute Resolution Panel. The decision to grant or deny this request is pending while the 

requester and CDRH attempt to resolve the dispute by other means.

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

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