Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life Cycle; Public Workshop, 391 [E9-31198]
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Federal Register / Vol. 75, No. 2 / Tuesday, January 5, 2010 / Notices
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.
srobinson on DSKHWCL6B1PROD with PROPOSALS
ACTION:
Notice of public workshop.
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
https://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 https://
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
VerDate Nov<24>2008
16:41 Jan 04, 2010
Jkt 220001
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 https://
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.
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.
SUPPLEMENTARY INFORMATION:
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
PO 00000
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Fmt 4703
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391
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 74 FR 48089–48090
dated September 21, 2009).
This notice reflects organizational
changes in the Health Resources and
Services Administration. Specifically,
this notice establishes the Office of
Special Health Affairs (RA1) and the
Office of Planning, Analysis and
Evaluation (RA5) within the Office of
the Administrator; transfers the
functions and renames the Office of
Minority Health and Health Disparities
(RA9) and the Office of International
Health Affairs (RAH) to the Office of
Special Health Affairs (RA1); establishes
the Office of Strategic Priorities (RA13)
within the Office of Special Health
Affairs (RA1); renames the Office of
Equal Opportunity and Civil Rights
(RA2); abolishes the Office of Health
Information Technology (RT) and moves
the functions to the Office of Planning,
Analysis and Evaluation (RA5), the
Office of Rural Health Policy (RH) and
the Bureau of Primary Health Care (RC);
and updates the functional statement for
the Healthcare Systems Bureau (RR), the
Bureau of Health Professions (RP), and
the Office of Operations (RB).
Chapter RA—Office of the
Administrator
Section RA–10, Organization
Delete in its entirety and replace with
the following:
The Office of the Administrator (RA)
is headed by the Administrator, Health
Resources and Services Administration,
who reports directly to the Secretary.
The OA includes the following
components:
(1) Immediate Office of the
Administrator (RA);
(2) Office of Equal Opportunity, Civil
Rights, and Diversity Management
(RA2);
(3) Office of Planning, Analysis, and
Evaluation (RA5);
(4) Office of Communications (RA6);
(5) Office of Special Health Affairs
(RA1); and
(6) Office of Legislation (RAE).
E:\FR\FM\05JAN1.SGM
05JAN1
]]>Agencies
[Federal Register Volume 75, Number 2 (Tuesday, January 5, 2010)]
[Notices]
[Page 391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-31198]
[[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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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
