[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Notices]
[Pages 4426-4431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0053]


Announcement of a Pilot Customer Satisfaction Survey: Medical 
Device Inspection Evaluation

AGENCY: Food and Drug Administration, HHS.


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ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-year 
pilot of a customer satisfaction survey entitled ``Medical Device 
Inspection Evaluation.'' The purpose of the evaluation is to provide a 
means whereby the medical device industry can provide feedback in an 
anonymous way to FDA's Office of Regulatory Affairs (ORA) regarding the 
medical device inspectional process. ORA intends to utilize a third 
party to collect the evaluations and trend the data submitted.

DATES: Written comments may be submitted at any time between March 1, 
1999, through February 28, 2000.

ADDRESSEES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Denise D. Dion, Office of Regulatory 
Affairs, Division of Emergency and Investigational Operations (HFC-
130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-5645, e-mail ``[email protected]''.

SUPPLEMENTARY INFORMATION: The Office of Management and Budget (OMB) 
has granted approval for this evaluation as a customer satisfaction 
survey. The evaluation is a followup to FDA/ORA's successful medical 
device industry initiatives, which included preannounced inspections, 
FDA 483 annotations, and postinspection notification letters. The 
Medical Device Industry Initiative Grassroots Taskforce, which includes 
members from industry and industry trade groups from across the nation 
as well as from FDA/ORA and FDA/Center for Devices and Radiological 
Health, is responsible for the design and development of this 
evaluation tool. The University of California-Irvine (UCI) Center for 
Statistical Consulting, Irvine, CA, is the third party that will 
collect and collate the evaluation forms and data. The data trends and 
findings will be made publicly available and will be shared with 
industry. The evaluation will be piloted for medical device 
preapproval, quality system/good manufacturing practices, and other 
related inspections.
    The evaluation forms will contain preprinted information completed 
by the investigator regarding the name of the firm inspected, date of 
inspection, whether an FDA 483 was issued, the name of the 
investigator(s), the applicable FDA District Office and the reason for 
the inspection. The form will be accompanied by a preaddressed stamped 
envelope that is to be used to return the form to the UCI Center for 
Statistical Consulting (UCI). FDA expects the firm official with the 
most knowledge of the inspection to complete the industry survey 
portion of the evaluation as soon as possible after the inspection has 
ended. UCI will report the results by FDA District, FDA Region and 
nationwide.
    The purpose of including investigator and firm identifiers on the 
evaluation is to assist UCI in obtaining clarifying information if 
needed and to determine the number of responses received versus the 
number of inspections conducted. FDA/ORA intends to share FDA's 
inspectional accomplishments (numbers) with UCI to help facilitate this 
determination of response rate. Neither the firm nor investigator 
identifier information will be entered into the data base or shared 
with FDA or industry.
    The information collection provisions in this notice have been 
approved under OMB control number 0910-0360. An agency may not conduct 
or sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.
    Interested persons may, at any time between March 1, 1999, through 
February 28, 2000, submit written comments to the Dockets Management 
Branch (address above). 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. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

BILLING CODE 4160-01-F

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    Dated: January 21, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-2014 Filed 1-27-99; 8:45 am]
BILLING CODE 4160-01-C