[Federal Register Volume 72, Number 196 (Thursday, October 11, 2007)]
[Notices]
[Page 57951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20077]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Quality System Regulation Educational Forum on Design Controls; 
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, Southwest Region, Dallas District Office, in collaboration 
with the FDA Medical Device Industry Coalition (FMDIC), is announcing a 
public workshop entitled ``Quality System Regulation Educational Forum 
on Design 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 4, 2008, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Omni Mandalay 
Hotel at Las Colinas, 221 East Las Colinas Blvd., Dallas (Irving), TX 
75039. Directions to the facility are available at the FMDIC Web site 
at http://www.fmdic.org/.
    Contact Person: David Arvelo, Food and Drug Administration, 4040 
North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, 
FAX: 214-253-4970, e-mail [email protected].
    Registration: FMDIC has a $250 early registration fee. Early 
registration ends March 21, 2008. Registration is $350 thereafter. 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. Registration 
onsite will be accepted 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 $350 payable to the FMDIC. The registration fee will be used to 
offset expenses of hosting the event, including meals, refreshments, 
meeting rooms, and materials.
    If you need special accommodations due to a disability, please 
contact David Arvelo (see Contact Person) at least 21 days in advance.
    Transcripts: Transcripts of this event will not be available due to 
the format of this workshop. Event handouts may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, 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 an outreach activity 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) 
Planning design controls, (2) design inputs and outputs, (3) design 
validation and verification, (4) design transfer and change, (5) 
control of suppliers, (6) design history file, and (7) how design 
controls relate to corrective and preventive action, change control, 
and risk management.

    Dated: October 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20077 Filed 10-10-07; 8:45 am]
BILLING CODE 4160-01-S