Document ID: FDA-2009-N-0664-0133
Agency: fda
Document Type: Notice
Title: Public Workshop: Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life Cycle
Posted Date: 2010-01-05T05:00Z

[Federal Register: January 5, 2010 (Volume 75, Number 2)]
[Notices]               
[Page 391]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja10-81]                         

[[Page 391]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
 Medical Device Quality System Regulation Educational Forum on 
Risk Management Through the Product Life Cycle; 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 (DALDO), 
in collaboration with the FDA Medical Device Industry Coalition 
(FMDIC), is announcing a public workshop entitled ``Medical Device 
Quality System Regulation Educational Forum on Risk Management through 
the Product Life Cycle.'' 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 2, 2010, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the new Cowboy 
Stadium in Irving, TX. 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: david.arvelo@fda.hhs.gov.
    Registration: FMDIC has a $250 early registration fee. Discounts 
for full-time students and government employees with valid 
identification are available. Early registration ends March 19, 2010. 
Registration is $300 thereafter. For more information on fees and/or 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 William 
Hyman, Texas A&M University, Department of Biomedical Engineering, 3120 
TAMU, College Station, TX 75843-3120. Registration on site 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 $300 
payable to the FMDIC. The registration fee will be used to offset 
expenses of hosting the event, including food, venue, and equipment.
    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. Digital event handouts will be posted 
online at http://www.fmdic.org/ or 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, 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. This workshop helps 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) 
Standards and guidance, (2) risk management in design, (3) risk 
management in execution, and (4) risk management and post market 
surveillance.

    Dated: December 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-31198 Filed 1-4-10; 8:45 am]

BILLING CODE 4160-01-S