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CDRH Ombudsman Annual Report - Calendar Year 2012

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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

 

 

1. 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% total of 461 in 2011. New cases were classified as follows 

Type201220112010
Inquiries217(44%)201(44%)206(50%)
Complaints224(45%)202(44%171(41%)
Disput41(8%)43(9%)26(6%)
Other11(2%)15(3%)11(3%)
Total493461414

B. Source of Contacts:

Type201220112010
Industry285278(60%)269(65%
Consumers124(25%)105(23%)93(23%)
Health Care Providers33(7%)33(7%)25(6%)
Internal employee24(5%)23(5%)-
Other27(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. 

Type201220112010
CD330(67%)125(27%)*61(15%)
CE17(3%)57(12%)35(8%)
OC21(4%)61(13%)85(21%)
ODE103(21%)163(35%)164(40%)
OIR9(2%)32(7%)41(10%)
OMO1(0.2%)0(0%)1(0.2%)
OSEL0(0%)5(1%)0(0.0%)
OSB12(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

CD: Office of the Center Director

CE: 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:* 
 

Type201220112010
510(k)Submission104 (21%)105 (23%)138 (33%
Adverse Event/MDR/Safety Issue123(25%)82(18%)70(17%)
Combination Product2(0.4%)3(1%)4(1%)
DeNovo Petition5(1.0%)11(2%)2(1%)
FOIA/Disclosure4(0.8%)5(1%)3(1%)
Import/Export24(5%)25(5%)25(6%)
Insspanpection13(2.6%7(2%)12(3%)
PMA/IDE/HDE Application38(8%)57(12%)55(13%)
Post-Market Study1(0.2%)8(2%)4(1%)
Pre-IDE Submission13(2.6%)7(2%)9(2%)
Registration and Listing Inquiry28(5.7%)19(4%)45(11%)
Trade Complaint30(6.1%)41(9%28(7%
Oth108(22%91(20%)19(5%)

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


E.  Reasons for Contacting Ombudsman:
  

Type201220112010
510(k) Request for Additional Informationn15(3%21(5%8(2%)
Complaint about CDRH employee10(2%6(1%)4(1%)
Data/Testing Requirements27(5.5%)27(6%)43(10%)
Level Playing field10(2%)16(3%)14(3%)
Practice of Medicine24(5%29(6%)26(6%)
Miscommunication/Lack of Communication99(20%)111(24%)88(21%)
PMA Not Approvable16(3.2%)13(3%)9(2%)
510(k)Not Substantially Equivalent28(6%)26(6%)21(5%)
Policies and Procedures176(36%)151(33%)193(46%)
Registration and Listing2(0.4%)14(3%)1(0%)
Other86(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:

Type201220112010
Referred to CDRH Subject Matter Expert56(11%)65(13%)86(24%)
Email response to inquirer137(27%)150(31%)83(24%)
Teleconference49(10%38(8%)48(14%)
Referred to OCER (DSMICA)55(11%)41(8%)34(10%)
Closed for inactivity54(11%)58(12%)27(8%)
Closed with letter59(12%)51(10%)13(4%)
No action requested or required32(6%)11(2%)13(4%)
Referred to FDA Ombudsman8 (1.6%)16 (3%)10
External meeting with inquirer10(2%)12(2%)8(2%)
Referred to another Center within FDA12(2%)21(4%)7(2%)
Referred to another Agency11(2%)7(1%)7(2%)
Internal meeting12(2%)8(2%)2(1%)
Other9(1.8%)9(2%)14(4%)

2. 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.

3. 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.

 

Page Last Updated: 05/19/2015
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