[Federal Register Volume 69, Number 43 (Thursday, March 4, 2004)]
[Notices]
[Pages 10237-10238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration and Food and Drug Administration 
Medical Device Industry Coalition Quality Systems Educational Forum: 
Production and Process Controls; Public Workshop

AGENCY: Food and Drug Administration, HHS.

[[Page 10238]]


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 (DALDO), 
in collaboration with the FDA Medical Device Industry Coalition (FMDIC) 
is announcing a public workshop entitled ``Quality Systems Educational 
Forum: Production and Process Controls.'' This public workshop is 
intended to provide information about FDA's Medical Device Quality 
Systems Regulation (QSR) to the regulated industry, particularly small 
businesses.
    Date and Time: The public workshop will be held on April 23, 2004, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Dallas Market Center Hotel, 7050 I-35 Stemmons Freeway, Dallas, TX 
75247. Directions to the facility are available at the FMDIC Web site 
at http://www.fmdic.org.\1\
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    \1\FDA has verified the Web site address, but FDA is not 
responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.
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    Contact Person: David Arvelo or Sue Thomason, Food and Drug 
Administration, 4040 North Central Expressway, suite 900, Dallas, TX 
75204, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail 
[email protected].
    Registration: FMDIC has a $150 early registration fee. Early 
registration begins on February 1 and ends March 26, 2004. Registration 
is $175 from March 27 to April 9, 2004. To register online, please 
visit http://www.fmdic.org/. As an alternative, you may send 
registration information including name, title, firm name, address, 
telephone and fax numbers, and e-mail along with a check or money order 
for the appropriate amount payable to the FMDIC to Dr. William Hyman, 
Texas A&M University, Department of Biomedical Engineering, 3120 Tamu, 
College Station, TX 75843-3120. Course space will be filled in order of 
receipt of registration with appropriate fees. Seats are limited, 
please submit registration form as soon as possible. Those accepted 
into the course will receive confirmation. Registration will close 
after the course is filled. Registration at the site will be done on a 
space available basis on the day of the public workshop beginning at 8 
a.m. The cost of registration at the site is $175 payable to the FMDIC. 
The registration fee will be used to offset expenses of hosting the 
conference, including meals, refreshments, meeting rooms, and 
materials.
    If you need special accommodations due to a disability, please 
contact David Arvelo or Sue Thomason at least 7 days in advance.
    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, approximately 15 working days after the public workshop at a 
cost of 10 cents per page.

SUPPLEMENTARY INFORMATION: The workshop is being held in response to 
the interest in the topics discussed from small medical device 
manufacturers in the Dallas District area. FMDIC and FDA present this 
workshop to help achieve objectives set forth in section 406 of the 
Food and Drug Administration Modernization Act of 1997 (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 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), as outreach activities by 
Government agencies to small businesses.
    The goal of the workshop is to present information that will enable 
manufacturers and regulated industry to better comply with the Medical 
Device QSR. The following topics will be discussed at the workshop: (1) 
The production and process control subsystem of the QSR, (2) FDA 483 
trends and applicable regulations, (3) the business friendly approach, 
(4) software validation, (5) process validation, (6) product acceptance 
including techniques and purchasing controls, and (7) device history 
records.

    Dated: February 26, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4785 Filed 3-3-04; 8:45 am]
BILLING CODE 4160-01-S