FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
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. You may also wish to see his web site at http://www.fda.gov/cdrh/ombudsman/.
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 |
||||||||
|
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 |
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 |
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. This Guidance is available at http://www.fda.gov/cdrh/resolvingdisputes/1121.pdf.
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.
Updated March 31, 2004
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH