[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Notices]
[Page 968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-92]


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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) and the Risk 
Management Small Business Development Center (RMSBDC), is announcing a 
public workshop entitled ``Medical Devices 101: An Educational Forum.'' 
This public workshop 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 February 9, 
2007, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hoblitzelle 
Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth 
St. in 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: [email protected].
    Registration: Registration by January 26, 2007, is strongly 
encouraged. The RMSBDC has a $75 early registration fee to cover the 
cost of facilities, materials, and refreshments. Please submit your 
registration as soon as possible. Registration at the site may be 
possible on a space available basis on the day of the public workshop 
beginning at 8 a.m. The cost of registration after January 26, 2007, is 
$99 payable to RMSBDC. If you need special accommodations due to a 
disability, please contact David Arvelo (see Contact Person) at least 7 
days in advance.
    Registration Form Instructions: To register, please complete the 
RMSBDC registration form and submit along with payment to RMSBDC, Attn: 
Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the 
completed registration form to RMSBDC at 214-860-5867. To obtain a copy 
of the registration form, please call RMSBDC at 214-860-5887 or 214-
860-5849. The registration form is also available online at http://www.ntsbdc.org/.
    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 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 
entrepreneurs and startup manufacturers in the Dallas District area. 
FDA presents this workshop in cosponsorship with FMDIC and RMSBDC 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 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, and 
(8) postmarket surveillance.

    Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-92 Filed 1-8-07; 8:45 am]
BILLING CODE 4160-01-S