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CDRH Ombudsman Annual Report - Calendar Year 2012
 | 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:
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
D. Types of Inquiries, Complaints, and Disputes:*
Type | 2012 | 2011 | 2010 |
510(k) Submission | 104 (21%) | 105 (23%) | 138 (33%) |
Adverse Event/MDR/Safety Issue | 123 (25%) | 82 (18%) | 70 (17%) |
Combination Product | 2 (0.4%) | 3 (1%) | 4 (1%) |
De Novo Petition | 5 (1.0%) | 11 (2%) | 2 (1%) |
FOIA/Disclosure | 4 (0.8%) | 5 (1%) | 3 (1%) |
Import/Export | 24 (5%) | 25 (5%) | 25 (6%) |
Inspection | 13 (2.6%) | 7 (2%) | 12 (3%) |
PMA/IDE/HDE Application | 38 (8%) | 57 (12%) | 55 (13%) |
Post-Market Study | 1 (0.2%) | 8 (2%) | 4 (1%) |
Pre-IDE Submission | 13 (2.6%) | 7 (2%) | 9 (2%) |
Registration and Listing Inquiry | 28 (5.7%) | 19 (4%) | 45 (11%) |
Trade Complaint | 30 (6.1%) | 41 (9%) | 28 (7%) |
Other | 108 (22%) | 91 (20%) | 19 (5%) |
* these categories are revised slightly from the 2009 and 2010 reports
E. Reasons for Contacting Ombudsman:
Type | 2012 | 2011 | 2010 |
510(k) Request for Additional Information | 15 (3%) | 21 (5%) | 8 (2%) |
Complaint about CDRH employee | 10 (2%) | 6 (1%) | 4 (1%) |
Data/Testing Requirements | 27 (5.5%) | 27 (6%) | 43 (10%) |
Level Playing field | 10 (2%) | 16 (3%) | 14 (3%) |
Practice of Medicine | 24 (5%) | 29 (6%) | 26 (6%) |
Miscommunication/Lack of Communication | 99 (20%) | 111 (24%) | 88 (21%) |
PMA Not Approvable | 16 (3.2%) | 13 (3%) | 9 (2%) |
510(k) Not Substantially Equivalent | 28 (6%) | 26 (6%) | 21 (5%) |
Policies and Procedures | 176 (36%) | 151 (33%) | 193 (46%) |
Registration and Listing | 2 (0.4%) | 14 (3%) | 1 (0%) |
Other | 86 (17%) | 47 (10%) | 7 (2%) |
F. Year-end Status of Inquiries, Complaints, and Disputes:
A total of 504 cases were closed in 2012, including all open cases from prior to January 1, 2012. There are 50 open cases remaining from 2012. Cases were closed as follows:
Type | 2012 | 2011 | 2010 |
Referred to CDRH Subject Matter Expert | 56 (11%) | 65 (13%) | 86 (24%) |
Email response to inquirer | 137 (27%) | 150 (31%) | 83 (24%) |
Teleconference | 49 (10%) | 38 (8%) | 48 (14%) |
Referred to OCER (DSMICA) | 55 (11%) | 41 (8%) | 34 (10%) |
Closed for inactivity | 54 (11%) | 58 (12%) | 27 (8%) |
Closed with letter | 59 (12%) | 51 (10%) | 13 (4%) |
No action requested or required | 32 (6%) | 11 (2%) | 13 (4%) |
Referred to FDA Ombudsman | 8 (1.6%) | 16 (3%) | 10 (3%) |
External meeting with inquirer | 10 (2%) | 12 (2%) | 8 (2%) |
Referred to another Center within FDA | 12 (2%) | 21 (4%) | 7 (2%) |
Referred to another Agency | 11 (2%) | 7 (1%) | 7 (2%) |
Internal meeting | 12 (2%) | 8 (2%) | 2 (1%) |
Other | 9 (1.8%) | 9 (2%) | 14 (4%) |
II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL
There were no meetings of the Medical Devices Dispute Resolution Panel in calendar year 2012. A petition was submitted to FDA in 2012 regarding a Premarket Approval Application (PMA) that may result in a meeting of the Panel in calendar year 2013.
III. REQUESTS FOR SUPERVISORY REVIEW (APPEALS)
On July 9, 2012, the FDA Safety and Innovation Act (FDASIA) was enacted. Section 603 of FDASIA modified the procedures for appeals of significant decisions rendered by CDRH, as follows: requests for supervisory review (appeal) submitted under 21 CFR 10.75 for significant decisions must be received by CDRH within 30 calendar days of the date of the decision in dispute; if an appeal meeting or teleconference is requested by the submitter, the meeting or teleconference will take place within 30 days of receipt of the appeal by CDRH, and a decision on the appeal will be rendered 30 days thereafter; if no meeting or teleconference is requested, a decision will be rendered within 45 days of receipt; however, the time frames for issuance of a decision do not apply to appeals referred to outside expertise.
Between July 9, 2012 and December 31, 2012, CDRH received a total of ten appeals of significant decisions, three at the Center level and seven at the Office level. All three Center-level appeals, and four of the seven Office-level appeals, have received a final decision; all decisions were rendered within the statutory time frames. Three Office-level appeals were received near the end of 2012 and remain under review.
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