[Federal Register: March 4, 2004 (Volume 69, Number 43)]
[Notices]
[Page 10237-10238]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr04-63]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
oraswrsbr@ora.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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