CDRH Ombudsman Annual Report

Calendar Year 2001

The CDRH Ombudsman, Les Weinstein, was appointed to this new position, located in the Office of the 

Center Director, in April, 2000. As an external Ombudsman, he investigates complaints from outside the 

agency, and facilitates the resolution of disputes between CDRH and the medical device industry it 

regulates. While providing this assistance, he maintains his impartiality and neutrality. A complaint is 

usually 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. The Ombudsman also receives a wide variety of device 

related questions from the public of a scientific, regulatory, or procedural nature. This Report includes 

statistics on complaints, disputes, and questions as well as information on some other activities and 

initiatives the Ombudsman has undertaken. You may also wish to see his web site at 

http://web.archive.org/web/20090120120718/http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html. 

This Annual Report is the first one the Ombudsman is issuing for a full calendar year. His 2000 Annual 

Report covered only the initial nine months that he was in this position, but statistics from that Report are 

included below for limited comparison purposes.

I. COMPLAINTS AND DISPUTES

Number Received:

When Ombudsman was contacted: (If related to a process such as submissions.)

Office: (Some involved more than one Office.)

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2001 2000 (April - December)

Complaints 51 24

Disputes 21 11

Total 72 35

2001 2000 (April - December)

As last resort 17% N/A

Earlier 60% N/A

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ODE by Division:

Subjects:

2001 2000

ODE 65% 61%

OC 27% 18%

OSB 3% N/A

OHIP 3% N/A

OSM 3% N/A

2001 2000

DRARD 4% 4%

DCLD 16% 9%

DGRND 31% 39%

DDIGD 12% 22%

DCRD 22% 26%

DOED 2% 0%

POS 12% N/A

2001 2000

510(k) 41% 51%

PMA 9% 6%

Inspections 8% N/A

IDE 4% N/A

Imports 4% N/A

Drugs of Abuse Tests 4% N/A

Advertising/Promotion 3% N/A

CLIA 3% N/A

AIP 3% N/A

Reuse 1% N/A

Leveraging 1% N/A

Recalls 1% N/A

Petitions 1% N/A

Registration/Listing 1% 6%

Website 1% N/A

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Issues by rank: (Some Complaints/Disputes involved more than issue.)

*Numbers in parentheses indicate ranking last year.

Status:

*Includes 72 complaints/disputes received in 2001 and 13 pending at the end of 2000 and carried over to 

2001.

Outcomes: (Of the complaints/disputes that were resolved.)

FOI 1% N/A

Other 14% 37%

2001 2000

1. Evidence requirements (data, testing) to support a 

submission; "least burdensome" 20% 15%(2)*

2. Policy/Procedures 18% 7% (4)

3. Timeliness (of approval/clearance; setting up meetings; 

returning phone calls; etc.) 17% 13% (3)

4. Miscommunication or lack of communication 15% 23% (1)

5. Level playing field (concerns regarding unequal treatment) 11% 4% (8)

6. Rude, difficult or unhelpful employees 2% 7% (5)

7. Claims of conflict of interest, bias, retaliation 2% 7% (6)

8. Jurisdiction over combination (drug/device) products 1% 3% (9)

9. Disclosure (FOIA) 1% 5% (7)

10. Allegations of employee incompetence 0% 3% (10)

11. Other 13% 15%

2001* 2000

Pending at year's end 36% 37%

Referred elsewhere 12% 11%

Withdrawn 13% N/A

Resolved 39% 51%

2001 2000

In favor of industry 39% 42%

In favor of CDRH 21% 17%

Mutual satisfaction 39% 41%

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Status and outcomes of complaints/disputes that involved evidence requirements as an issue:

II. QUESTIONS

In addition to his involvement in complaints and disputes, the Ombudsman receives many device related 

questions from the public by phone, fax and email to which he responds, often in consultation with other 

CDRH offices, or refers to those offices for a direct reply. 

From: 

Subjects: (Five most common.)

III. DISPUTE RESOLUTION PANEL

2001 2000

Resolved 54% N/A

In favor of industry 27% N/A

In favor of CDRH 47% N/A

Mutual satisfaction 27% N/A

2001 2000

Number Received 101 29

2001 2000

Industry 56% 41%

Consumers 25% 28%

Health care providers 15% 10%

State government 3% N/A

Media 2% N/A

Academia 1% N/A

Other 0% 21%

2001 2000

Status of submission 10% 14%

IDE/human subjects 9% 14%

Combination products 9% 10%

Imports 7% N/A

Labeling 5% 10%

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On July 2 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://web.archive.org/web/20090120120718/http://www.fda.gov/cdrh/resolvingdisputes/1121.pdf.

The Ombudsman granted the first request for the newly created Medical Devices Dispute Resolution Panel 

to review a scientific dispute. The request was submitted by Lifecore Biomedical which was appealing a 

decision by CDRH that Lifecore's pre-market approval application (PMA) for Intergel Adhesion Prevention 

Solution was not approvable. The Panel meeting was held on September 6. The Panel voted unanimously to 

recommend that the PMA be approved. The Center Director subsequently concurred with this 

recommendation, and the PMA was approved. No other requests for review of a dispute by this Panel have 

been received.

IV. QUALITY ASSURANCE SURVEYS 

As part of his Quality Assurance Manager role, the Ombudsman attends meetings that Center staff has with 

device firms and sponsors. Afterwards he surveys the industry participants to get feedback on the meeting. 

The Ombudsman also surveyed sponsors and applicants on their experiences specifically with Agreement 

and Determination Meetings and with Day 100 Meetings. 

Updated 5/8/2002

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