CDRH Ombudsman Annual Report - Calendar Year 2008

U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health

Les Weinstein was appointed as the first CDRH Ombudsman in 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, disputes, and inquiries: the number of contacts the Ombudsman received, their source, the CDRH offices involved, the subjects, reasons and disposition.

I. CONTACTS

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. An inquiry may be a question or an issue that does not rise to the level of a complaint or a dispute.

A. Number received: 170

Complaints: 54%
Disputes: 18%
Inquiries: 28%

B. Source of Contacts:

Industry: 81%
Consumers: 8%
Health Care Providers: 5%
Misc: 6%

C. CDRH Office mentioned in Complaints, Disputes, and Inquiries; or Office referred to by the Ombudsman for assistance in resolution or response:
(Some may include more than one Office.)

Office of Center Director (OCD): 1%
Office of Communication, Education, and Radiation Programs (OCER): 4%
Office of Compliance (OC): 26%
Office of Device Evaluation (ODE): 65%
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD): 9%
Office of Management Operations (OMO): 1%
Office of Science and Engineering Laboratories (OSEL): 0 %
Office of Surveillance and Biometrics (OSB): 1%

D. Subject of Complaints, Disputes, and Inquiries: (Only those 2% or more of the total are listed.)

510(k): 19%
PMA/IDE/HDE: 8%
Imports: 5%
Registration & Listing: 5%
513g: 3%
Adverse Event/MDR/Safety: 3%
Inspection: 3%
Classification/Reclassification: 3%
Clinical Trial: 3%
Company Whistleblower: 3%
De Novo: 2%
Laser: 2%
Combination Product: 2%
FOIA/Disclosure: 2%
Pre-IDE: 2%
CDRH Meetings with Company: 2%
FDA Website: 2%
Recall: 2%

E. Most Common Reasons for Complaints, Disputes, and Inquiries by rank:

1. Miscommunication or lack of communication
2. Data/testing requirements to support a submission; not “least burdensome”
3. Lack of timeliness (of approval/clearance; scheduling meetings; returning phone calls, etc.)
4. Various policies and procedures
5. Level playing field (claim of unequal treatment)

F. Year-end Status of Complaints, Disputes, and Inquiries, excluding those that were referred outside CDRH, withdrawn, or had no follow-up by the initiator: (Includes cases received in 2008 plus those pending from previous years that had been carried over to 2008.)

Closed (Complaint addressed, dispute resolved, or inquiry responded to): 81%
Pending at end of 2008: 19%

II. MEDICAL DEVICES DISPUTE RESOLUTION PANEL

In 2008, the Ombudsman did not receive any requests for review of a scientific dispute by the Medical Devices Dispute Resolution Panel.