[Federal Register: January 28, 1999 (Volume 64, Number 18)]
[Notices]
[Page 4426-4431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja99-83]

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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 ``ddion@ora.fda.gov''.

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