[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]


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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: 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 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