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

In 2011 the Office of the CDRH Ombudsman implemented an electronic tracking system that 

facilitates record-keeping and trending. 

The CDRH Ombudsman received a total of 461 new contacts in 2011, an increase of 11% from a 

total of 414 in 2010. New cases were classified as follows:

B. Source of Contacts:

* beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH 

for internal employee inquiries, complaints and differences of opinion not handled by other

CDRH Ombudsman Annual Report - Calendar Year 2011

U.S. Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Devices and Radiological Health

I. CONTACTS

Type 2011 2010 2009

Inquiries 201 (44%) 206 (50%) 65 (26%)

Complaints 202 (44%) 171 (41%) 132 (53%)

Disputes 43 (9%) 26 (6%) 53 (21%)

Other 15 (3%) 11 (3%) -

Total 461 414 250

Type 2011 2010 2009

Industry 278 (60%) 269 (65%) 175 (70%)

Consumers 105 (23%) 93 (23%) 42 (17%)

Health Care Providers 33 (7%) 25 (6%) 23 (9%)

Internal employee* 23 (5%) - -

Other 22 (5%) 27 (6%) 10 (4%)

About FDA

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means.

C. CDRH Office

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to 

the OCD category for tracking purposes

Key:

OC: Office of Compliance

OCD: Office of the Center Director

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

OSB: Office of Surveillance and Biometrics

OSEL: Office of Science and Engineering Laboratories

D. Types of Inquiries, Complaints, and Disputes:*

Type 2011 2010 2009

OCD 125 (27%)* 61 (15%) 15 (6%)

OCER 57 (12%) 35 (8%) 15 (6%)

OC 61 (13%) 85 (21%) 42 (17%)

ODE 163 (35%) 164 (40%) 135 (54%)

OIVD 32 (7%) 41 (10%) 10 (4%)

OMO 0 (0%) 1 (0.2%) 5 (9%)

OSEL 5 (1%) 0 (0.0%) 5 (2%)

OSB 18 (4%) 27 (7%) 10 (4%)

Type 2011 2010 2009

510(k) Submission 105 (23%) 138 (33%) 38 (15%)

Adverse Event/MDR/Safety Issue 82 (18%) 70 (17%) 10 (4%)

Combination Product 3 (1%) 4 (1%) 8 (3%)

De Novo Petition 11 (2%) 2 (1%) 13 (5%)

FOIA/Disclosure 5 (1%) 3 (1%) 20 (8%)

Import/Export 25 (5%) 25 (6%) 8 (3%)

Inspection 7 (2%) 12 (3%) 8 (3%)

PMA/IDE/HDE Application 57 (12%) 55 (13%) 23 (9%)

Post-Market Study 8 (2%) 4 (1%) 8 (3%)

Pre-IDE Submission 7 (2%) 9 (2%) 13 (5%)

Registration and Listing Inquiry 19 (4%) 45 (11%) 13 (5%)

Trade Complaint 41 (9%) 28 (7%) 18 (7%)

Other 91 (20%) 19 (5%) 70 (28%)

* these categories are revised slightly from the 2009 and 2010 reports

E. Reasons for Contacting Ombudsman:*

Type 2011 2010 2009

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510(k) Request for Additional Information 21 (5%) 8 (2%) 2 (1%)

Complaint about CDRH employee 6 (1%) 4 (1%) 0 (0%)

Data/Testing Requirements 27 (6%) 43 (10%) 59 (24%)

Level Playing field 16 (3%) 14 (3%) 7 (3%)

Practice of Medicine 29 (6%) 26 (6%) 0 (0%)

Miscommunication/Lack of Communication 111 (24%) 88 (21%) 39 (16%)

PMA Not Approvable 13 (3%) 9 (2%) 1 (0%)

510(k) Not Substantially Equivalent 26 (6%) 21 (5%) 3 (1%)

Policies and Procedures 151 (33%) 193 (46%) 114 (46%)

Registration and Listing 14 (3%) 1 (0%) 3 (1%)

Other 47 (10%) 7 (2%) 22 (9%)

* these categories are revised slightly from the 2009 and 2010 reports

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

A total of 487 cases were closed in 2011, including: one from 2007, 10 from 2009 and 82 from 

2010. Three cases remain open from 2010 and 60 cases remain open from 2011. Cases were closed 

as follows:

Type 2011 2010 2009*

Referred to CDRH Subject Matter Expert 65 (13%) 86 (24%)

Email response to inquirer 150 (31%) 83 (24%)

Teleconference 38 (8%) 48 (14%)

Referred to OCER (DSMICA) 41 (8%) 34 (10%)

Closed for inactivity 58 (12%) 27 (8%)

Closed with letter 51 (10%) 13 (4%)

No action requested or required 11 (2%) 13 (4%)

Referred to FDA Ombudsman 16 (3%) 10 (3%)

External meeting with inquirer 12 (2%) 8 (2%)

Referred to another Center within FDA 21 (4%) 7 (2%)

Referred to another Agency 7 (1%) 7 (2%)

Internal meeting 8 (2%) 2 (1%)

Other 9 (2%) 14 (4%)

* closure type was not tracked in 2009

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 Approval Application 

(PMA). The Panel meeting, scheduled to take place in December 2011, was canceled at the request

of the parties. 

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

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