[Federal Register Volume 66, Number 80 (Wednesday, April 25, 2001)]
[Notices]
[Page 20819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10165]



[[Page 20819]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-0053]


Medical Device Inspection Evaluation Report; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Medical Device Inspection 
Evaluation Report.'' The report describes the outcomes of the Medical 
Device Inspection Evaluation pilot conducted between March 1, 1999, and 
February 29, 2000. The report was prepared by the University of 
California at Irvine Statistical Consulting Center from the information 
received on the evaluation forms submitted by medical device 
manufacturers who were inspected for their compliance with the quality 
system/good manufacturing practices (QS/GMP) during the time of the 
pilot.

DATES: Submit written comments on this report at any time.

ADDRESSES: Submit written requests for single copies of the report to 
the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Submit written 
comments on the report to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the report.

FOR FURTHER INFORMATION CONTACT: Denise Dion, Division of Emergency and 
Investigational Operations (HFC-130), Office of Regional Operations, 
Office of Regulatory Affairs, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5645, FAX 301-443-6919.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a report entitled ``Medical 
Device Inspection Evaluation Report.'' In the Federal Register of 
January 28, 1999 (64 FR 4426, January 28, 1999), at the close of all 
premarket and QS/GMP inspections conducted between March 1, 1999, and 
February 29, 2000, an FDA investigator provided a survey packet to the 
device firm's representative. This survey packet included a 
questionnaire, a postage-paid return envelope, and a cover letter to 
the company explaining the questionnaire's purpose. FDA officials; 
industry representatives; and Dr. Anita Iannucci, the survey 
coordinator/data analyst from the University of California at the 
Irvine Center for Statistical Consulting, signed this cover letter. To 
maintain confidentiality, the firms mailed their completed 
questionnaires directly to the university survey coordinator.
    The purpose of the survey was to: (1) Give firms an opportunity to 
provide feedback to FDA and industry about their inspection experience, 
(2) compare the consistency of firms' reactions to inspections across 
different areas (both domestic and international), and (3) determine if 
the medical device industry initiatives (preannounced inspections and 
annotated FDA 483s) were being followed. The survey was also designed 
to determine if the initiative caused officials in medical device firms 
to view their FDA inspections in a more positive light than they had 
previously.
    FDA's Office of Regulatory Affairs received the complete tabulation 
of the responses, and purged of all identifying information. FDA will 
be reviewing the report to determine if areas of future improvement can 
be identified. The information will be used internally to identify 
suggestions for training.
    An FDA/industry committee consisting of: Nancy Singer, AdvaMed; 
Denise Dion, FDA; Lauren Andersen, AdvaMed and Andersen Caledonia Ltd.; 
Elaine Messa, Quintiles Consulting and Former Director of the Los 
Angeles District Office, FDA; Leif Olsen, AMDM and BioWhittaker; and 
Susan Reilly, ASQ Biomedical Division and Reilly and Associates, worked 
with Dr. Iannucci in designing the survey and assisting in the 
evaluation of the results. The committee members also assisted in the 
preparation of the final report.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the report at any time. Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. A copy of the report and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ora under the heading ``Recent Publications.''

    Dated: April 18, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-10165 Filed 4-24-01; 8:45 am]
BILLING CODE 4160-01-S