[Federal Register: May 28, 2002 (Volume 67, Number 102)]
[Notices]
[Page 36898-36899]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my02-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Device Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Southwest Region (SWR), Dallas District Office, in
collaboration with the FDA Medical Device Industry Coalition (FMDIC),
is announcing a public workshop entitled ``Medical Device Workshop.''
This public workshop is intended to provide information about FDA's
medical device quality systems regulation (QSR) to regulated industry
and, in particular, to small businesses.
Date and Time: The public workshop will be held on July 19, 2002,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the Texas A&M
University Health Science Center, Baylor College of Dentistry, 3302
Gaston Ave., sixth floor, Dallas, TX 75246. Directions to the facility
are available on the Internet at the Texas A&M University Health
Science Center, Baylor College of Dentistry at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.tambcd.edu/.
Contact: David Arvelo or Sue Thomason, Southwest Regional Office
(HFR-SW16), Food and Drug Administration, 7920 Elmbrook Dr., suite 102,
Dallas, TX 75247, 214-655-8100, ext. 130 or 128, FAX 214-655-8114, or
e-mail: oraswrsbr@ora.fda.gov.
Registration: Preregistration by June 7, 2002, is encouraged. FMDIC
has a $150 preregistration fee. To preregister, please complete the
form provided in this document and send it along with a check or money
order for $150 payable to the FMDIC, c/o FDA/SWR/Small Business
Representative, 7920 Elmbrook Dr., suite 102, Dallas, TX 75247. As an
alternative, the registration form can also be obtained on the Internet
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.geocities.com/Eureka/Suite/3316/. Seats are limited.
Please submit registration forms as soon as possible. Course space will
be filled in order of receipt of registration. Those accepted into the
course will receive written confirmation. Registration will close once
the course is filled. Onsite registration will be done on a space-
available basis on the day of the public workshop beginning at 8:30
a.m. The cost of registration at the site is $175, payable to the
FMDIC. If you need special accommodations due to a disability, please
contact David Arvelo or Sue Thomason at least 7 days in advance.
The following information is requested for registration purposes:
Name:
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Company:
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Mailing
address:
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City: ....................... State: ...................... Zip code: ......................
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Phone: ....................... FAX:
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E-mail:
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[[Page 36899]]
SUPPLEMENTARY INFORMATION: The workshop is being held in response to
the interest that small medical device manufacturers in the Dallas
District area have expressed in the topics that will be addressed at
the workshop. FMDIC and FDA will present this workshop to help achieve
objectives set forth in section 903 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 393), which include working closely with
stakeholders and maximizing the availability and clarity of information
to stakeholders and the public. This workshop is also consistent with
the purposes of FDA's Regional Small Business Program, which are in
part to respond to industry inquiries, develop educational materials,
sponsor workshops and conferences to provide firms, particularly small
businesses, with firsthand working knowledge of FDA's requirements and
compliance policies. This workshop is also consistent with the Small
Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-
121), because it is an outreach activity by a government agency
directed at small businesses.
The goal of the workshop is to present information that will enable
manufacturers and regulated industry to better comply with the QSR (21
CFR part 820). Information presented will be based on agency position
as articulated through regulation, compliance policy guides, and
information previously made available to the public. Topics to be
discussed at the workshop include: (1) Analysis of FDA 483s, (2)
analysis of FDA warning letters, (3) how corrective and preventive
actions (CAPA) relates to QSR and the Quality System Inspection
Technique, (4) designing and implementing a CAPA system, and (5) the
role of complaint files in a CAPA system.
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Course handouts may be
requested in writing from the Freedom of Information Office (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville,
MD 20857, starting approximately 15 working days after the public
workshop at a cost of 10 cents per page.
Dated: May 22, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-13282 Filed 5-22-02; 3:52 pm]
BILLING CODE 4160-01-S