[Federal Register: August 21, 2007 (Volume 72, Number 161)]
[Notices]               
[Page 46638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au07-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Medical Devices 101: An Educational Forum; 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 Regional Office (SWRO), in cosponsorship with 
the FDA Medical Device Industry Coalition (FMDIC), is announcing a 
public workshop entitled ``Medical Devices 101: An Educational Forum.'' 
This public workshop, presented previously on February 9, 2007, is 
intended to provide an overview on FDA's medical device requirements to 
entrepreneurs, startup companies, and small businesses.
    Date and Time: The public workshop will be held on October 26, 
2007, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA SWRO, 4040 
North Central Expressway, 9th floor conference room, Dallas, TX.
    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: oraswrsbr@fda.hhs.gov.
    Registration: FMDIC has a $75 early registration fee. The early 
registration fee for government officials is $50 and for students is 
$25 with positive identification. Early registration ends October 12, 
2007. After October 12, 2007, registration is $100 for the public at 
large, $75 for government officials, and $50 for students with positive 
identification. 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 mail your registration information including 
name, title, organization or company name, physical address, telephone 
and fax numbers, and e-mail address, 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. The available space will be filled in 
order of receipt of registration with appropriate fees. Seats are very 
limited; please submit registration as soon as possible. Those accepted 
into the course will receive confirmation. Registration will close 
after the course is filled. Registration at the site may be available 
based on space availability on the day of the public workshop beginning 
at 8 a.m. The cost of registration at the site is $99 payable to FMDIC. 
The registration fee will be used to offset expenses associated with 
this event including lunch, refreshments, and course materials.
    If you require special accommodations due to a disability, please 
contact David Arvelo (see Contact Person) at least 21 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. 6-30, Rockville, 
MD 20857, approximately 15 working days after the public workshop at an 
estimated cost of 10 cents per page.

SUPPLEMENTARY INFORMATION: The workshop, previously presented on 
February 9, 2007 (72 FR 968, January 9, 2007), is being held in 
response to the interest in the topics discussed from small medical 
device entrepreneurs and startup manufacturers in the Dallas District 
area. FDA presents this workshop in cosponsorship with FMDIC 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, and 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 Quality System Regulation. The following topics will be broadly 
covered at the workshop: (1) Medical device classification; (2) 
establishment registration; (3) device listing; (4) premarket 
notification; (5) premarket approval; (6) quality system regulation; 
(7) labeling; (8) recalls, removals, and corrections; (9) medical 
device reporting; (10) tracking; and (11) postmarket surveillance.

    Dated: August 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16375 Filed 8-20-07; 8:45 am]

BILLING CODE 4160-01-S