[Federal Register Volume 67, Number 102 (Tuesday, May 28, 2002)]
[Notices]
[Pages 36898-36899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13282]


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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://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: [email protected].
    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://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