About FDA
CDRH Ombudsman Annual Report - Calendar Year 2003
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 statistics about complaints and disputes: the number the Ombudsman received, their source, the CDRH Offices involved, the subjects, reasons and disposition.
I. COMPLAINTS AND DISPUTES
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 Complaints and Disputes:
C. CDRH Office mentioned in Complaints and Disputes or referred to by the Ombudsman for resolution:
|
2003
2002
2001
D. When the Ombudsman was contacted, if related to a process such as premarket submission:
E. Subject of Complaints and Disputes: (Only those 2% of the total or more are listed.)
| 2003 | 2002 | 2001 | |
|---|---|---|---|
| 510(k)’s | 25% | 42% | 41% |
| PMA’s | 9% | 11% | 9% |
| Imports | 6% | 8% | 4% |
| Competitors/Trade Complaints | 6% | 2% | n/a |
| IDE’s | 4% | 11% | 4% |
| 513g’s | 4% | 2% | n/a |
| Adverse Events/MDR | 4% | 2% | n/a |
| Reuse/Reprocessing | 3% | 2% | 1% |
| GMP/QSR | 3% | n/a | n/a |
| Mammography | 3% | 2% | n/a |
| Registration and Listing | 3% | n/a | n/a |
| FDA Website | 3% | n/a | n/a |
| Advertising/Promotion | 2% | 3% | 3% |
| Recalls | 2% | 2% | 1% |
| EMS | 2% | 2% | n/a |
| Disclosure | 2% | 2% | 1% |
| Lasers | 2% | n/a | n/a |
F. Most common reasons for Complaints and Disputes by rank: (Some involved more than one reason.)
| 2003 | 2002* | 2001* | |
|---|---|---|---|
| 1. Miscommunication or lack of communication | 22% | 16% (2) | 15% (4) |
| 2. Lack of timeliness (of approval/clearance; setting up meetings; returning phone calls; etc.) | 18% | 9% (5) | 17% (3) |
| 3. Data, testing requirements to support a premarket submission; “least burdensome” | 16% | 26% (1) | 20% (1) |
| 4. Various policies and procedures | 13% | 12% (4) | 18% (2) |
| 5. Level playing field (claims of unequal treatment) | 9% | 14% (3) | 11% (5) |
| 6. Difficult or unhelpful employees | 9% | 6% (7) | 2% (6) |
| 7. Safety concerns/issues | 4% | n/a | n/a |
| 8. Freedom of Information Act (FOIA) | 3% | 7% (6) | 1% (9) |
| 9. Combination products | 2% | 2% (8) | 1% (8) |
| 10. Claims of conflict of interest, bias, or retaliation | 2% | 1% (9) | 2% (7) |
*Numbers in parentheses indicate rankings in previous years.
G. Status of Complaints and Disputes:
2003 *
* Includes 120 complaints/disputes received in 2003 and 25 pending
at the end of 2002 that were carried over to 2003 for a total of 145.
2002
2001
H. Status of Complaints and Disputes excluding those that were referred outside CDRH, withdrawn or had no follow-up by complainant:
2003*
*Includes complaints /disputes received in 2003 plus those
pending at the end of 2002 that were carried over to 2003.
2002
2001
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 2003 the Ombudsman received one request for review of a scientific dispute by the Medical Devices Dispute Resolution Panel, which he granted, but the scheduled meeting of the Panel was subsequently postponed indefinitely. In 2002 the Ombudsman did not receive any requests for this Panel to review a scientific dispute. In 2001 he received one such request, which he granted, and the Panel reviewed the dispute in September 2001.