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CDRH Ombudsman Annual Report - Calendar Year 2010

Posted Jan 14 2011 12:00am

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


An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a 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. Total Number Received

There were 11 cases open at the beginning of 2010. As of January 1, 2011, nine were closed and two cases remained to be resolved. The CDRH Ombudsman received a total of 414 new contacts in 2010, as follows:

Inquiries: 206 (49.8%)
Complaints: 171 (41.3%)
Disputes: 26 (6.3%)
Other: 11 (2.7%)

B. Source of Contacts:

Industry: 269 (65.0%)
Consumers: 93 (22.5%)
Other: 27 (6.5%)
Health Care Providers: 25 (6.0%)

C. CDRH Office

Office of Device Evaluation (ODE): 164 (39.6%)
Office of Compliance (OC): 85 (20.5%)
Office of the Center Director (OCD): 61 (14.7%)
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD): 41 (9.9%)
Office of Communication, Education, and Radiation Programs (OCER): 35 (8.4%)
Office of Surveillance and Biometrics: 27 (6.5%)
Office of Management Operations (OMO): 1 (0.2%)

D. Most Common Subject of Inquiries, Complaints, and Disputes:

Policies and Procedures: 193 (46.6%)
Data/Testing Requirements: 43 (10.4%)
510(k) Not Substantially Equivalent: 21 (5.1%)
510(k) Request for Additional Information: 8 (1.9%)
PMA Not Approvable: 9 (2.2%)

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

Miscommunication/Lack of Communication: 88 (21.3%)
Level Playing Field: 14 (3.4%)
Complaints about CDRH Employees: 4 (1.0%)
De Novo Petition: 2 (0.5%)
Other: 6 (1.4%)
Medical Practice: 26 (6.3%)

F. Year-end Status of Inquiries, Complaints, and Disputes:

As of January 1, 2011, 352 cases had been closed. Two cases were pending from pre-2010 and 62 cases were either actively in progress or were on hold for various reasons. Cases opened in 2010 were closed as follows:

Referred to CDRH Subject Matter Expert: 86 (24.4%)
E-mail response to inquirer: 83 (23.6%)
Teleconference: 48 (13.6%)
Referred to OCER (DSMICA): 34 (9.7%)
Closed for Inactivity (lack of response to follow-up communication): 27 (7.7%)
Other: 14 (4.0%)
Closed with Letter: 13 (3.7%)
No Action Requested or Required: 13 (3.7%)
Referred to FDA Ombudsman: 10 (2.8%)
External Meeting with Inquirer: 8 (2.3%)
Referred to Another Center: 7 (2.0%)
Referred to Other Agency: 7 (2.0%)
Internal Meeting: 2 (0.6%)


In 2010, the Ombudsman was directed by the FDA Commissioner’s Office to convene the Medical Devices Dispute Resolution Panel to consider a matter related to a Pre-Market Application (PMA). The Panel will be convened in 2011.

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