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CDRH Ombudsman's Annual Report - Calendar Year 2006
|
U.S. Department
of Health and Human Services |
Les Weinstein was appointed as the first CDRH Ombudsman in April 2000. As an external Ombudsman, he looks into complaints from outside the agency and facilitates the resolution of disputes between CDRH and the medical device industry it regulates. While providing this service, he maintains his impartiality and neutrality. This Annual Report focuses on complaints and disputes: the number of contacts the Ombudsman received, their source, the CDRH offices involved, the subjects, reasons and disposition. You may also wish to see his web site at: http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.
Most contacts the Ombudsman receives are in the form of a complaint or 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.
54 Complaints
40 Disputes
26 Other
Industry: 78%
Consumers: 9%
Health Care Providers: 3%
Miscellaneous: 10%
Office of the Center Director (OCD): 4%
Office of Compliance (OC): 21%
Office of Communication, Education and Radiation Programs (OCER): 12%
(Includes 9% that were referred for assistance to the Division of Small Manufacturers, International and
Consumer Assistance (DSMICA.))
Office of Device Evaluation (ODE): 45%
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD): 4%
Office of Management Operations (OMO): 2%
Office of Science and Engineering Laboratories (OSEL): 2%
Office of Surveillance and Biometrics (OSB): 2%
Other: 8%
| 510(k) | 29% |
| IDE/HDE | 7% |
| PMA | 6% |
| Advertising/Promotion | 5% |
| 513(g) | 4% |
| Adverse Event | 4% |
| Trade Complaint | 4% |
| Import | 3% |
| Inspection | 3% |
| GMP/QSR | 3% |
| Laser | 3% |
| Registration & Listing | 3% |
| Safety Concern/Issue | 3% |
| Company Whistleblower | 3% |
| Drug or Device? | 2% |
| Labeling | 2% |
| Mammography | 2% |
| Warning Letter | 2% |
| FOIA/Disclosure | 2% |
| Combination Product | 2% |
| 2006 ( Numbers in parentheses indicate rank the previous year.) |
|---|
| 1. Miscommunication or lack of communication (1) |
| 2. Data, testing requirements to support a submission; “least burdensome” (2) |
| 3. Level playing field (claim of unequal treatment) (6) |
| 4. Various policies and procedures (5) |
| 5. Lack of timeliness (of approval/clearance; setting up meetings; returning phone calls; etc.) (3) |
| 6. Safety concern/issue (4) |
| 7. Difficult or unhelpful employee (7) |
Resolved: 81%*
Pending at end of 2006: 19%*
* Includes complaints/disputes, etc. received in 2006 plus those pending from previous years that were carried over to 2006.
On July 2, 2001 the Guidance for industry and FDA entitled “Resolving Scientific Disputes Concerning the Regulation of Medical Devices: a Guide to Use of the Medical Devices Dispute Resolution Panel” was issued. This Guidance is available at http://www.fda.gov/cdrh /resolvingdisputes/1121.pdf.
In 2006 the Ombudsman received three requests for review of a scientific dispute by the Medical Devices Dispute Resolution Panel. Of these, the Ombudsman granted two and denied one. Of the two he granted, the Panel heard one of the disputes at a December 15, 2006 meeting and the other at an April 19, 2007 meeting.
Updated August 22, 2007
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