The 12th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference; “Regulatory Affairs: The Challenges of Ensuring Product Safety”, 16217 [E9-8135]
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Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices
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only upon valid scientific evidence to
determine whether there is reasonable
assurance of the safety and effectiveness
of the device, if regulated by general
controls alone (class I) or by general
controls and special controls (class II).
Valid scientific evidence consists of
evidence from well-controlled
investigations, partially controlled
studies, studies and objective trials
without matched controls, welldocumented case histories conducted by
qualified experts, and reports of
significant human experience with a
marketed device, from which it can
fairly and responsibly be concluded by
qualified experts that there is reasonable
assurance of the safety and effectiveness
of a device under its conditions of use.
The evidence required may vary
according to the characteristics of the
device, its conditions of use, the
existence and adequacy of warnings and
other restrictions, and the extent of
experience with its use. Isolated case
reports, random experience, reports
lacking sufficient details to permit
scientific evaluation, and
unsubstantiated opinions are not
regarded as valid scientific evidence to
show safety or effectiveness (see
§ 860.7(c)(2)).
According to § 860.7(d)(1), there is
reasonable assurance that a device is
safe when it can be determined, based
upon valid scientific evidence, that the
probable benefits to health from use of
the device for its intended uses and
conditions of use, when accompanied
by adequate directions and warnings
against unsafe use, outweigh any
probable risks. The valid scientific
evidence used to determine the safety of
a device shall adequately demonstrate
the absence of unreasonable risk of
illness or injury associated with the use
of the device for its intended uses and
conditions for use. Moreover, under
§ 860.7(e)(1), there is reasonable
assurance that a device is effective when
it can be determined, based upon valid
scientific evidence, that in a significant
portion of the target population, the use
of the device for its intended uses and
conditions of use, when accompanied
by adequate directions for use and
warnings against unsafe use, will
provide clinically significant results.
IV. Submission of Required Information
The summary of, and citation to, any
information required by the act must be
submitted by the dates listed in the
DATES section of this document to the
Division of Dockets Management (see
ADDRESSES).
VerDate Nov<24>2008
15:28 Apr 08, 2009
Jkt 217001
V. Paperwork Reduction Act of 1995
This order refers to collections of
information necessary to comply with
the requirements found in sections
510(k) of the act (21 U.S.C. 360(k)) and
21 CFR part 807, subpart E or the
requirements of 515(b) of the act (21
U.S.C. 360e(b)), 21 CFR part 860, and 21
CFR part 814. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
860.123 have been approved under
OMB control number 0910–0138; the
collections of information in 21 CFR
part 814, have been approved under
OMB control number 0910–0231; and
the collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120.
Dated: April 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8022 Filed 4–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
The 12th Annual Food and Drug
Administration-Orange County
Regulatory Affairs Educational
Conference; ‘‘Regulatory Affairs: The
Challenges of Ensuring Product
Safety’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing the following
conference: 12th Annual Educational
Conference co-sponsored with the
Orange County Regulatory Affairs
Discussion Group (OCRA). The
conference is intended to provide the
Drug, Device, and Biologics industries
with an opportunity to interact with
FDA reviewers and compliance officers
from the Centers and District Offices, as
well as other industry experts. The main
focus of this interactive conference will
be product approval, compliance, and
risk management in the three medical
product areas. Industry speakers,
interactive questions and answers, and
workshop sessions will also be included
to assure open exchange and dialogue
on the relevant regulatory issues.
PO 00000
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16217
Date and Time: The conference will
be held on June 9 and 10, 2009, from
7:30 a.m. to 5 p.m.
Location: The conference will be held
at the Irvine Marriott Hotel, 18000 Von
Karman Ave., Irvine, CA 92612.
Contact: Linda Hartley, Food and
Drug Administration, 19701 Fairchild,
Irvine, CA 92612, 949–608–4413, FAX:
949–608–4417, or OCRA, Attention to
Detail, 5319 University Dr., suite 641,
Irvine, CA 92612, 949–387–9046, FAX:
949–387–9047, Web site: https://
www.ocra-dg.org.
Registration and Meeting Information:
See OCRA Web site, https://www.ocradg.org. Contact Attention to Detail at
949–387–9046.
Before May 8, 2009, registration fees
are as follows: $675.00 for members,
$725.00 for nonmembers and $475.00
for FDA/Govt/Students.1 After May 8,
2009, $725.00 for members, $775.00 for
nonmembers, and $475.00 for FDA/
Govt/Students.1
The registration fee will cover actual
expenses including refreshments, lunch,
materials, parking, and speaker
expenses.
If you need special accommodations
due to a disability, please contact Linda
Hartley at least 10 days in advance.
Dated: April 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8135 Filed 4–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
1 OCRA Student Rate applies to those individuals
enrolled in a Regulatory or Quality related
academic program at an accredited institution.
Proof of enrollment required.
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 74, Number 67 (Thursday, April 9, 2009)]
[Notices]
[Page 16217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8135]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
The 12th Annual Food and Drug Administration-Orange County
Regulatory Affairs Educational Conference; ``Regulatory Affairs: The
Challenges of Ensuring Product Safety''
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
conference: 12th Annual Educational Conference co-sponsored with the
Orange County Regulatory Affairs Discussion Group (OCRA). The
conference is intended to provide the Drug, Device, and Biologics
industries with an opportunity to interact with FDA reviewers and
compliance officers from the Centers and District Offices, as well as
other industry experts. The main focus of this interactive conference
will be product approval, compliance, and risk management in the three
medical product areas. Industry speakers, interactive questions and
answers, and workshop sessions will also be included to assure open
exchange and dialogue on the relevant regulatory issues.
Date and Time: The conference will be held on June 9 and 10, 2009,
from 7:30 a.m. to 5 p.m.
Location: The conference will be held at the Irvine Marriott Hotel,
18000 Von Karman Ave., Irvine, CA 92612.
Contact: Linda Hartley, Food and Drug Administration, 19701
Fairchild, Irvine, CA 92612, 949-608-4413, FAX: 949-608-4417, or OCRA,
Attention to Detail, 5319 University Dr., suite 641, Irvine, CA 92612,
949-387-9046, FAX: 949-387-9047, Web site: https://www.ocra-dg.org.
Registration and Meeting Information: See OCRA Web site, https://www.ocra-dg.org. Contact Attention to Detail at 949-387-9046.
Before May 8, 2009, registration fees are as follows: $675.00 for
members, $725.00 for nonmembers and $475.00 for FDA/Govt/Students.\1\
After May 8, 2009, $725.00 for members, $775.00 for nonmembers, and
$475.00 for FDA/Govt/Students.\1\
---------------------------------------------------------------------------
\1\ OCRA Student Rate applies to those individuals enrolled in a
Regulatory or Quality related academic program at an accredited
institution. Proof of enrollment required.
---------------------------------------------------------------------------
The registration fee will cover actual expenses including
refreshments, lunch, materials, parking, and speaker expenses.
If you need special accommodations due to a disability, please
contact Linda Hartley at least 10 days in advance.
Dated: April 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8135 Filed 4-8-09; 8:45 am]
BILLING CODE 4160-01-S
