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U.S. Department of Health and Human Services

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CDRH Ombudsman Annual Report - Calendar Year 2012

CDRH Logo

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
 
 
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.