ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance, 50113-50114 [2012-20322]
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50113
Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
P&A SGP .........................................................................................................
57
1
44
2,508
Estimated Total Annual Burden
Hours: 2,508.
Dated: August 15, 2012.
Kathy Greenlee,
Administrator & Assistant Secretary for
Aging.
[FR Doc. 2012–20418 Filed 8–17–12; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0841]
ASTM International-Food and Drug
Administration Workshop on
Absorbable Medical Devices: Lessons
Learned From Correlations of Bench
Testing and Clinical Performance
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘ASTM International-FDA Workshop on
Absorbable Medical Devices: Lessons
Learned From Correlations of Bench
Testing and Clinical Performance.’’ FDA
is co-sponsoring the workshop together
with ASTM International, an
organization responsible for the
development and delivery of
international voluntary consensus
standards for engineered products,
including medical devices. The purpose
of this public workshop is to provide a
forum for highlighting and discussing
the use of absorbable materials in
medical devices across a broad range of
indications with the aim of defining
successful and unsuccessful methods to
predict clinical performance. The main
topics to be discussed include
identification of test methods for
establishing correlations between in
vitro and in vivo degradation of
absorbable implant devices, and the
interaction of mechanical loading and
mechanical performance with
degradation. While there will be an
emphasis on cardiovascular indications
as part of a panel session,
characterization techniques and
experiences from both cardiovascular as
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:25 Aug 17, 2012
Jkt 226001
well as non-cardiovascular devices will
be discussed and are encouraged.
Date and Time: The public workshop
will be held on November 28, 2012,
from 8:30 a.m. to 5 p.m. EST.
Location: The public workshop will
be held at the FDA’s White Oak
Campus, 10903 New Hampshire Ave.,
Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD,
20993–0002. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Contact Person: Maureen Dreher,
Center for Devices and Radiological
Health (CDRH), Food and Drug
Administration, Bldg. 62, rm. 2110,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–2505,
Fax: 301–796–9932, email:
Maureen.dreher@fda.hhs.gov; or Erica
Takai, CDRH, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–6353, Fax: 301–796–9959,
email: erica.takai@fda.hhs.gov.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by November 13, 2012. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permits, onsite registration on the
day of the workshop will be provided
beginning at 8 a.m.
If you need special accommodations
due to a disability, please contact Cindy
Garris, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4321, Silver Spring, MD, 20993–
0002, 301–796–5861, email:
cynthia.garris@fda.hhs.gov, at least 7
days in advance of the workshop.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number. Those without
Internet access should contact Maureen
Dreher or Erica Takai to register (see
Contact Person). Registrants will receive
confirmation after they have been
accepted. You will be notified if you are
on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. Persons interested in
viewing the Webcast must register
online by November 13, 2012, 5 p.m.
EST. Early registration is recommended
because Webcast connections are
limited. Organizations are requested to
register all participants, but to view
using one connection per location.
Webcast participants will be sent
technical system requirements after
registration and will be sent connection
access information after November 23,
2012. If you have never attended a
Connect Pro event before, test your
connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This
public workshop includes presentations
in topic-focused sessions. If you wish to
present at the workshop, please submit
an abstract at: https://www.astm.org/
f04wkshp1112.htm.
FDA has included general topics in
this document. Following the close of
the call for abstracts, FDA and ASTM
International members of the workshop
organizing committee will determine
the amount of time allotted to each
presenter, the approximate time each
oral presentation is to begin, and will
select and notify participants by October
1, 2012. All requests to make oral
presentations must be received by the
close of the call for abstracts on
September 1, 2012. If selected for
presentation, any presentation materials
must be emailed to Maureen Dreher (see
Contact Person) no later than November
E:\FR\FM\20AUN1.SGM
20AUN1
50114
Federal Register / Vol. 77, No. 161 / Monday, August 20, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
23, 2012. No commercial or promotional
material will be permitted to be
presented or distributed at the public
workshop.
Comments: FDA is holding this public
workshop through co-sponsorship with
ASTM International to obtain
information on test methods for
establishing correlations between in
vitro and in vivo degradation of
absorbable devices. In order to permit
the widest possible opportunity to
obtain public comment, FDA is
soliciting either electronic or written
comments on all aspects of the public
workshop topics. The deadline for
submitting comments related to this
public workshop is December 28, 2012.
Regardless of attendance at the public
workshop, interested persons may
submit either written comments
regarding this document to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852 or electronic comments to
https://www.regulations.gov. It is only
necessary to send one set of comments.
Please identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the
transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
SUPPLEMENTARY INFORMATION:
I. Background
Recent studies have identified
promising results for the use of
absorbable materials in implantable
devices for endovascular therapies such
as fully absorbable cardiovascular stents
where the stent platform degrades, in
addition to absorbable coatings. The use
of these materials for cardiovascular
indications, however, poses new risks
VerDate Mar<15>2010
16:25 Aug 17, 2012
Jkt 226001
due to the critical fatigue and
mechanical loading demands that the
implant must withstand and perform.
Moreover, the optimal preclinical/bench
testing paradigm to predict clinical
performance of fully absorbable
cardiovascular devices is not yet
defined.
This public workshop will discuss the
use of absorbable materials (including
synthetic polymers as well as erodible
metals) in medical devices across a
broad range of indications with the aim
of defining successful and unsuccessful
methods to predict clinical
performance, and will subsequently
apply lessons learned to unique
challenges for cardiovascular
indications. Therefore, we invite
presenters to share their experience
with respect to cardiovascular and noncardiovascular medical devices, both
those that are fully absorbable and those
with only a component or coating that
is absorbable.
This public workshop will bring
together the expertise of academia and
industry professionals to define test
methods as well as to educate and
inform industry, academia, and device
regulators on the performance and
predictability of absorbable medical
device degradation. Workshop
participants will seek to define the
critical factors for preclinical/bench
testing and clinical predictability. They
will then apply lessons learned from
marketed devices for non-cardiovascular
indications to the emerging uses of
absorbable devices to treat
cardiovascular disease.
II. Topics for Discussion at the Public
Workshop
Topics to be discussed at the public
workshop include, but are not limited
to:
• Correlations of in vitro and in vivo
absorption
• Quantitative characterization of
absorption kinetics
• Test methods to identify
interactions of absorption with
mechanical loading
• Test methods to assess mechanical
performance of the absorbable product
The lessons learned from both early
cardiovascular and well-established
non-cardiovascular device experiences
will be presented. These lessons will be
discussed in the context of emerging
cardiovascular uses of absorbable
materials as part of a panel session at
the end of the workshop.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Dated: August 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20322 Filed 8–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
029
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 029’’ (Recognition List
Number: 029), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit written or electronic
comments concerning this document at
any time. See section VII of this
document for the effective date of the
recognition of standards announced in
this document.
ADDRESSES: Submit written requests for
single copies of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 029’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993. Send two selfaddressed adhesive labels to assist that
office in processing your requests, or fax
your request to 301–847–8149. Submit
written comments concerning this
document, or recommendations for
additional standards for recognition, to
the contact person (see FOR FURTHER
INFORMATION CONTACT). Submit
electronic comments by email:
standards@cdrh.fda.gov. This document
may also be accessed on FDA’s Internet
site at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
SUMMARY:
E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50113-50114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20322]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0841]
ASTM International-Food and Drug Administration Workshop on
Absorbable Medical Devices: Lessons Learned From Correlations of Bench
Testing and Clinical Performance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``ASTM International-FDA Workshop on
Absorbable Medical Devices: Lessons Learned From Correlations of Bench
Testing and Clinical Performance.'' FDA is co-sponsoring the workshop
together with ASTM International, an organization responsible for the
development and delivery of international voluntary consensus standards
for engineered products, including medical devices. The purpose of this
public workshop is to provide a forum for highlighting and discussing
the use of absorbable materials in medical devices across a broad range
of indications with the aim of defining successful and unsuccessful
methods to predict clinical performance. The main topics to be
discussed include identification of test methods for establishing
correlations between in vitro and in vivo degradation of absorbable
implant devices, and the interaction of mechanical loading and
mechanical performance with degradation. While there will be an
emphasis on cardiovascular indications as part of a panel session,
characterization techniques and experiences from both cardiovascular as
well as non-cardiovascular devices will be discussed and are
encouraged.
Date and Time: The public workshop will be held on November 28,
2012, from 8:30 a.m. to 5 p.m. EST.
Location: The public workshop will be held at the FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD, 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Maureen Dreher, Center for Devices and Radiological
Health (CDRH), Food and Drug Administration, Bldg. 62, rm. 2110, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2505, Fax:
301-796-9932, email: Maureen.dreher@fda.hhs.gov; or Erica Takai, CDRH,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 301-796-6353, Fax: 301-796-9959, email:
erica.takai@fda.hhs.gov.
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by November 13, 2012. Early registration
is recommended because facilities are limited and, therefore, FDA may
limit the number of participants from each organization. If time and
space permits, onsite registration on the day of the workshop will be
provided beginning at 8 a.m.
If you need special accommodations due to a disability, please
contact Cindy Garris, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4321, Silver Spring, MD, 20993-0002, 301-796-5861,
email: cynthia.garris@fda.hhs.gov, at least 7 days in advance of the
workshop.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Maureen Dreher or Erica Takai to
register (see Contact Person). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by November 13, 2012, 5 p.m. EST. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after November 23, 2012. If you have never attended
a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This public workshop includes
presentations in topic-focused sessions. If you wish to present at the
workshop, please submit an abstract at: https://www.astm.org/f04wkshp1112.htm.
FDA has included general topics in this document. Following the
close of the call for abstracts, FDA and ASTM International members of
the workshop organizing committee will determine the amount of time
allotted to each presenter, the approximate time each oral presentation
is to begin, and will select and notify participants by October 1,
2012. All requests to make oral presentations must be received by the
close of the call for abstracts on September 1, 2012. If selected for
presentation, any presentation materials must be emailed to Maureen
Dreher (see Contact Person) no later than November
[[Page 50114]]
23, 2012. No commercial or promotional material will be permitted to be
presented or distributed at the public workshop.
Comments: FDA is holding this public workshop through co-
sponsorship with ASTM International to obtain information on test
methods for establishing correlations between in vitro and in vivo
degradation of absorbable devices. In order to permit the widest
possible opportunity to obtain public comment, FDA is soliciting either
electronic or written comments on all aspects of the public workshop
topics. The deadline for submitting comments related to this public
workshop is December 28, 2012.
Regardless of attendance at the public workshop, interested persons
may submit either written comments regarding this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments
to https://www.regulations.gov. It is only necessary to send one set of
comments. Please identify comments with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
SUPPLEMENTARY INFORMATION:
I. Background
Recent studies have identified promising results for the use of
absorbable materials in implantable devices for endovascular therapies
such as fully absorbable cardiovascular stents where the stent platform
degrades, in addition to absorbable coatings. The use of these
materials for cardiovascular indications, however, poses new risks due
to the critical fatigue and mechanical loading demands that the implant
must withstand and perform. Moreover, the optimal preclinical/bench
testing paradigm to predict clinical performance of fully absorbable
cardiovascular devices is not yet defined.
This public workshop will discuss the use of absorbable materials
(including synthetic polymers as well as erodible metals) in medical
devices across a broad range of indications with the aim of defining
successful and unsuccessful methods to predict clinical performance,
and will subsequently apply lessons learned to unique challenges for
cardiovascular indications. Therefore, we invite presenters to share
their experience with respect to cardiovascular and non-cardiovascular
medical devices, both those that are fully absorbable and those with
only a component or coating that is absorbable.
This public workshop will bring together the expertise of academia
and industry professionals to define test methods as well as to educate
and inform industry, academia, and device regulators on the performance
and predictability of absorbable medical device degradation. Workshop
participants will seek to define the critical factors for preclinical/
bench testing and clinical predictability. They will then apply lessons
learned from marketed devices for non-cardiovascular indications to the
emerging uses of absorbable devices to treat cardiovascular disease.
II. Topics for Discussion at the Public Workshop
Topics to be discussed at the public workshop include, but are not
limited to:
Correlations of in vitro and in vivo absorption
Quantitative characterization of absorption kinetics
Test methods to identify interactions of absorption with
mechanical loading
Test methods to assess mechanical performance of the
absorbable product
The lessons learned from both early cardiovascular and well-
established non-cardiovascular device experiences will be presented.
These lessons will be discussed in the context of emerging
cardiovascular uses of absorbable materials as part of a panel session
at the end of the workshop.
Dated: August 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20322 Filed 8-17-12; 8:45 am]
BILLING CODE 4160-01-P
