Medical Devices 101: An Educational Forum; Public Workshop, 46638 [E7-16375]
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46638
Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / Notices
Dated: August 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–16470 Filed 8–20–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Medical Devices 101: An Educational
Forum; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC64 with NOTICES
ACTION:
Notice of public workshop.
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 https://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
VerDate Aug<31>2005
15:08 Aug 20, 2007
Jkt 211001
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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
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et seq.). To request a copy of the
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The Office of Rural Health Policy
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data collection of user information for
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purpose of the Black Lung Clinics
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Grantees provide specific diagnostic and
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Data from the annual report will
provide quantitative information about
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Notices]
[Page 46638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16375]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
