FDA | CDRH Ombudsman Annual Report – Calendar Year 2012

CDRH Ombudsman Annual Report – Calendar Year 2012 | Regulatory Doctor

 

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

 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:
The CDRH Ombudsman received a total of 493 new contacts in 2012, an increase of 7%
from a total of 461 in 2011. New cases were classified as follows:
Type 2012 2011 2010
Inquiries 217 (44%) 201 (44%) 206 (50%)
Complaints 224 (45%) 202 (44%) 171 (41%)
Disputes 41 (8%) 43 (9%) 26 (6%)
Other 11 (2%) 15 (3%) 11 (3%)
Total 493 461 414
B.  Source of Contacts:
Type 2012 2011 2010
Industry 285 (58%) 278 (60%) 269 (65%)
Consumers 124 (25%) 105 (23%) 93 (23%)
Health Care Providers 33 (7%) 33 (7%) 25 (6%)
Internal employee* 24 (5%) 23 (5%)
Other 27 (5%) 22 (5%) 27 (6%)

* 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
This section includes inquiries, complaints and disputes that either involved the Office listed or were referred by the Ombudsman to the Office for resolution.
Type 2012 2011 2010
OCD 330 (67%)* 125 (27%)* 61 (15%)
OCE 17 (3%) 57 (12%) 35 (8%)
OC 21 (4%) 61 (13%) 85 (21%)
ODE 103 (21%) 163 (35%) 164 (40%)
OIR 9 (2%) 32 (7%) 41 (10%)
OMO 1 (0.2%) 0 (0%) 1 (0.2%)
OSEL 0 (0%) 5 (1%) 0 (0.0%)
OSB 12 (2%) 18 (4%) 27 (7%)

* beginning in 2011, inquiries handled within the Office of the Ombudsman were assigned to the OCD category for tracking purposes. In 2012 most complaints handled by the Ombudsman were assigned to OCD.

Key:
OC: Office of Compliance
OCD: Office of the Center Director
OCE: Office of Communication and Education
ODE: Office of Device Evaluation
OIR: Office of In Vitro Diagnostics and Radiological Health
OMO: Office of Management Operations
OSB: Office of Surveillance and Biometrics
OSEL: Office of Science and Engineering Laboratories

via CDRH Ombudsman > CDRH Ombudsman Annual Report – Calendar Year 2012.

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