[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Pages 14054-14055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05411]



Food and Drug Administration

[Docket No. FDA-2014-N-0253]

Methods for Thrombogenicity Testing; Public Workshop; Request for 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Workshop on Methods for Thrombogenicity 
Testing.'' Planned topics of discussion include the optimization of in 
vitro and in vivo thrombogenicity test methods and the identification 
of alternative in vitro tests.
    Date and Time: The public workshop will be held on April 14, 2014, 
from 9 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (rm. 1503, sections B and C), 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 Persons: Anchal Kaushiva, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1266, Silver Spring, MD 20993-0002, 301-796-6330, 
FAX: 301-847-8115, email: anchal.kaushiva@fda.hhs.gov, or James 
Kleinedler, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1102, Silver 
Spring, MD 20993-0002, 301-796-9448, FAX: 301-847-8115, email: 
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by April 4, 2014, at 5 p.m., EST. 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 Susan Monahan, 301-796-5661, email: susan.monahan@fda.hhs.gov 
no later than April 4, 2014.
    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 
and select this public workshop from the posted events list. Please 
provide complete contact information for each attendee, including name, 
title, and affiliation, email, and telephone number. Those without 
Internet access should contact Susan Monahan to register. 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 April 4, 2014, at 5 p.m. Early registration is 
recommended because

[[Page 14055]]

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 April 10, 2014. 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.)
    Comments: FDA is holding this public workshop to obtain information 
on in vitro and in vivo thrombogenicity test methods. 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 May 14, 2014.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., EST, 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.)


I. Background

    Thrombosis, or blood clot formation, is a major complication in the 
use of blood-contacting medical devices. Thrombosis often leads to 
device malfunction and severe adverse events such as stroke or 
myocardial infarction. To improve device quality and reduce the 
occurrence of thrombus formation, it is important to fully assess the 
thrombogenic potential of a medical device prior to clinical use and 
make material or geometrical modifications if necessary.
    The current thrombogenicity test paradigm relies heavily on animal 
studies. For implanted devices, where animal studies are often 
conducted to assess safety and possible effectiveness, thrombogenicity 
endpoints can also be included. However, for many interventional 
devices, where other animal studies are not commonly requested, FDA has 
traditionally recommended a 4-hour in vivo canine thrombogenicity test 
model for assessment of thrombogenic potential. Because there have been 
questions about the consistency, reliability, and clinical relevance of 
this 4-hour canine thrombogenicity model, FDA is interested in 
optimizing the conduct of this in vivo test and/or identifying 
alternative in vitro tests that provide equivalent or improved clinical 
insight into the potential for thrombogenicity of medical devices while 
minimizing expenses and animal use, if possible.
    This workshop will bring together academia, industry professionals, 
and FDA regulators to discuss the advantages, limitations, and 
optimization of both in vivo and in vitro thrombogenicity test methods, 
and identify alternative in vitro tests that show promising clinical 
relevance. We will discuss testing methods related to a broad range of 
blood contacting devices, especially for cardiovascular applications. 
Ideas generated during this workshop may facilitate development of new 
guidance and/or standards for thrombogenicity testing that optimize 
current in vivo methods and/or utilize in vitro methods.

II. Topics for Discussion at the Public Workshop

    FDA seeks to address and receive comments on the following topics:
    1. Strengths, weaknesses, and optimization of in vivo 
thrombogenicity test methods;
    2. Current methodologies for conducting in vitro thrombogenicity 
testing (e.g., blood conditions, static versus dynamic methods, and 
different test endpoints);
    3. Correlation between in vitro/in vivo thrombogenicity test 
results and clinical outcomes;
    4. Special testing considerations for catheters, stents, grafts, 
ventricular assist devices, and bypass circuit components.

    Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05411 Filed 3-11-14; 8:45 am]