[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Notices]
[Page 968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-50]
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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: oraswrsbr@fda.hhs.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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