About FDA
CDRH Ombudsman Annual Report - Calendar Year 2011
 | U.S. Department of Health and Human Services |
I. CONTACTS
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:
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 |
B. Source of Contacts:
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%) |
* 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 means.
C. CDRH Office
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%) |
* 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 |
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 |
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
II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL
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.
