About FDA
CDRH Ombudsman Annual Report - Calendar Year 2004
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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.
I. CONTACTS
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.
A. Number received:
B. Source of Contacts:
C. CDRH Office either mentioned in Complaints, Disputes and other contacts or referred to by the Ombudsman for resolution or a response:
Key:
| OCD | Office of Center Director | OC | Office of Compliance |
| OCER | Office of Communication, Education, and Radiation Programs (Formerly Office of Health and Industry Programs - OHIP) |
ODE | Office of Device Evaluation |
| OIVD | Office of In Vitro Diagnostic Device Evaluation and Safety | OMO | Office of Management Operations (Formerly Office of Systems and Management - OSM) |
| OSEL | Office of Science and Engineering Laboratories (Formerly Office of Science and Technology - OST) | OSB | Office of Surveillance and Biometircs (OSB) |
2003
2004
2002
D. When the Ombudsman was contacted, if related to a process such as premarket submission:
E. Subject of Complaints, Disputes and other contacts: (Only those 2% of the total or more are listed.)
| 2004 | 2003 | 2002 | |
|---|---|---|---|
| 510(k) | 28% | 25% | 42% |
| Imports | 7% | 6% | 8% |
| Competitor/Trade Complaint | 7% | 6% | 2% |
| 513g | 6% | 4% | 2% |
| IDE | 6% | 4% | 11% |
| PMA | 6% | 9% | 11% |
| FOIA | 5% | 7% | 1% |
| Registration & Listing | 4% | 3% | 0% |
| Inspection | 4% | 0% | 0% |
| Breast Implants | 3% | 2% | 0% |
| Exports | 3% | 1% | 2% |
| User Fees | 2% | 1% | n/a |
| HDE | 2% | 0% | 0% |
| Combination Product | 2% | 2% | 1% |
F. Most common reasons for Complaints and Disputes by rank: (Some involved more than one reason.)
| 2004 | 2003* | 2002* | |
|---|---|---|---|
| 1. Miscommunication or lack of communication | 25% | 22% (1) | 16% (2) |
| 2. Data, testing requirements to support a submission; “least burdensome” | 16% | 16% (3) | 26% (1) |
| 3. Various policies and procedures | 14% | 13% (4) | 12% (4) |
| 4. Lack of timeliness (of approval/clearance; setting up meetings; returning phone calls; etc.) | 12% | 18% (2) | 9% (5) |
| 5. Level playing field (claim of unequal treatment) | 7% | 9% (5) | 14% (3) |
| 6. Difficult or unhelpful employee | 6% | 9% (6) | 6% (6) |
| 7. Claim of conflict of interest, bias or retaliation | 2% | 2% (10) | 1% (9) |
| 8. Safety concern/issue | 2% | 4% (7) | n/a |
*The numbers in parentheses indicate rankings in previous years.
G. Status of Complaints and Disputes:
2004*
*Includes complaints/disputes received in 2004 plus those pending at the end of 2003 that were carried over to 2004.
2003
2002
H. Status of Complaints and Disputes excluding those that were referred outside CDRH, withdrawn or had no follow-up by complainant:
2004*
| *Includes complaints/disputes received in 2004 plus those pending at the end of 2003 that were carried over to 2004. |
2003
2002
II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL
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 in Final.
In 2004 the Ombudsman did not receive any requests for review of a scientific dispute by the Medical Devices Dispute Resolution Panel. In 2003 the Ombudsman received one request, which he granted, but the scheduled meeting of the Panel was subsequently postponed indefinitely. In 2002 the Ombudsman did not receive any requests. In 2001 he received one request, which he granted, and the Panel reviewed the dispute in September 2001.