[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Pages 5813-5815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2583]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0057]
Cardiovascular Metallic Implants: Corrosion, Surface
Characterization, and Nickel Leaching; Public Workshop
AGENCY: Food and Drug Administration, HHS.
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ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Cardiovascular Metallic Implants: Corrosion,
Surface Characterization, and Nickel Leaching.'' The purpose of this
public workshop is to provide a forum for FDA, cardiovascular device
manufacturers, test houses, and academia to discuss corrosion, surface
characterization, and nickel leach testing, as well as to collect
comments and input regarding when these assessments should be
considered.
Dates and Time: The public workshop will be held on March 8 and 9,
2012, from 9 a.m. to 5:30 p.m. EST.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503 (the Great Room),
Silver Spring, MD 20993. For parking and security information, please
visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The
public workshop will also be available to be viewed online via webcast.
Contact Persons:
Erica Takai, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
(301) 796-6353, FAX: (301) 796-9959, email: erica.takai@fda.hhs.gov; or
Nicole Ibrahim, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
(301) 796-5171, email: nicole.ibrahim@fda.hhs.gov.
Registration: To register for the public workshop, please visit the
following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to http://www.fda.gov and
select the FDA Medical Devices News & Events--Workshops & Conferences
calendar and 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. For those without Internet access, please call the Contact
Person to register. Registration is mandatory as space is limited and
onsite registration will not be available. FDA may limit the number of
participants from each organization. There is no registration fee for
the public workshop. Registration requests should be received by 5 p.m.
E.S.T. on February 21, 2012.
If you need special accommodations due to a disability, please
contact Susan Monahan, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD 20993, (301) 796-
5661 or email: susan.monahan@fda.hhs.gov at least 7 days in advance of
the workshop.
Streaming Webcast of the Public Workshop: This workshop will also
be webcast. Persons interested in viewing the webcast must register
online by 5 p.m. E.S.T. on February 21, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but view using one connection
per location. Webcast participants will be sent technical system
requirements after registration, and will be sent connection access
information in a final confirmation email by 5 p.m. E.S.T. on March 2,
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).
Workshop Participation: Participation in the workshop will consist
of both lead participants and audience members. Lead participants will
include representatives from various organizations involved in or who
perform corrosion testing, surface characterization, and/or nickel
leach testing and toxicological assessments of nickel, such as
industry, the medical community, and test houses, and will be driving
the discussions. Lead participants are expected to complete a work
assignment in advance of the workshop in order to optimize the time
spent during the workshop. FDA will compile the work assignment
responses prior to the workshop so that any information provided from
the responding organization is de-identified.
If you wish to participate as a lead participant, you must indicate
this at the time of registration. There will be a tentative limit of
one lead participant per organization for industry and two for test
houses for each session, with a total workshop participation limit of
two industry participants and three for test houses, due to space
limitations. Audience members may be able to participate in
discussions, if time permits.
Additional Information: Background information on the public
workshop, registration information, agenda, information about lodging,
food services, and other relevant information will be posted, as it
becomes available, on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to
http://www.fda.gov and select the FDA Medical Devices News & Events--
Workshops and Conferences calendar and select this public workshop from
the posted events list).
Comments: FDA is holding this public workshop to obtain information
on a number of questions regarding corrosion, surface characterization,
and nickel leaching. In order to permit the widest possible opportunity
to obtain public comment, FDA is soliciting written or electronic
comments on all aspects of the workshop topics. The deadline for
submitting comments related to this public workshop is April 6, 2012.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments. Submit electronic
comments to http://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. In addition, when
responding to specific topics as outlined in section II of this
document, please identify the topic you are addressing. 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.
SUPPLEMENTARY INFORMATION:
I. Background and Objectives
While the majority of cardiovascular implants are made of metals
and may be susceptible to corrosion, it is unclear whether the current
corrosion testing paradigm is predictive of in vivo corrosion outcomes,
or if there may be more suitable assessments to predict corrosion
failure. In addition, there has been an increase in the use of nitinol,
a nickel-titanium alloy, in cardiovascular implants due to its
superelastic properties, which are ideal for transcatheter-delivered
therapies. Corrosion of implant devices made of nitinol and other
nickel-containing metal alloys (e.g. stainless steel, MP35N) results in
the release of nickel ions,
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which may lead to various modes of toxicities. Furthermore, both nickel
ion release and corrosion characteristics are dependent on surface
finishing for nitinol as well as for some other nickel-containing
alloys. Through the collection of information from a pre-workshop work
assignment and discussions with workshop participants, FDA will be able
to better determine what assessments may be considered for
cardiovascular implants made of commonly used metallic alloys, and this
information is expected to serve as the foundation for a future
guidance document.
II. Topics for Discussion at the Public Workshop
The objective of this workshop is to provide a forum for discussion
of the following topics:
The various methods that are used for corrosion
assessments, surface characterization techniques, and nickel leach
testing used to evaluate the suitability of metallic cardiovascular
implant devices;
The limitations of each of these tests to predict actual
in vivo performance;
The need and utility for each test; and
The potential testing paradigms, including when certain
tests should be considered, and how to establish acceptance criteria
for each test.
III. 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 (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the
posted events list), approximately 45 days after the public workshop.
Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2583 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P