[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50113-50114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20322]
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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.
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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 http://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: [email protected]; 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:
[email protected].
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: [email protected], 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 http://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 http://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: http://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 http://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 http://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://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
http://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