
[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


