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Medical Devices

Public Workshop – Methods for Thrombogenicity Testing, April 14, 2014

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Methods for Thrombogenicity Testing”.

The purpose of this workshop was to discuss the advantages and limitations of both in vivo and in vitro thrombogenicity test methods. Methods related to the testing of blood contacting devices for a broad range of cardiovascular applications was discussed. Ideas generated during this workshop will facilitate development of new guidance and standards for thrombogenicity testing optimizing current in vivo methods and/or utilizing in vitro methods.

Date, Time and Location

This meeting was held April 14, 2014, beginning at 9:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

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Preliminary Agenda

TimeSubjectName of Speaker/
8:00–9:00 amRegistration 
9:00–9:15 amWelcome and Overview of the Current FDA Approach to Thrombogenicity EvaluationJen Goode, FDA
9:15–9:30 amRates of Thrombus Events in Blood Contacting Medical DevicesAnchal Kaushiva, FDA
9:30–9:45 amEvaluation of Blood HypercoagulabilityDennis Galanakis, Stony Brook University Medical Center
9:45–10:15 amThrombogenicity Testing in the 21st Century: Time for Alternative Strategies for Medical Devices?Mike Wolf, Medtronic, Inc.
10:15–10:30 amDiscussion 
10:30–10:45 amBreak 
10:45–10:50 amSummary of Results from Pre-Workshop Assignment: In Vivo PracticesJames Kleinedler, FDA
10:50–11:10 amFDA Perspective: Insights on Thrombogenicity from the Large Animal Safety StudiesMichael John, FDA
11:10–11:30 amAlternative Interventional/Surgical Methods for the In-vivo Thrombogenicity TestKent Grove, American Preclinical Services, LLC
11:30–11:45 amSummary of Results from Pre-Workshop Assignment: In Vitro PracticesJames Kleinedler, FDA
11:45–11:55 amThe Use of PTT and PT Assays for Thrombogenicity Evaluation: An FDA PerspectiveQijin Lu, FDA
11:55 am–12:15 pmHemocompatibility Testing in the 21st Century: Options and PitfallsHans Wendel, University Hospital Tuebingen, Germany
12:15–1:00 pmLunch 
1:00–1:20 pmPossibilities of Thrombogenicity Testing by means of In Vitro SystemsWim van Oeveren, HaemoScan
1:20–2:20 pmPanel Discussion 
2:20–2:25 pmSummary of Results from Pre-Workshop assignment: Device Specific ConsiderationsJames Kleinedler, FDA
2:25–2:45 pmIn-vitro Blood Flow Models for the Assessment of Thrombosis: Device Specific ChallengesSivaprasad Sukavaneshvar, Thrombodyne Inc.
2:45–3:05 pmChallenges in Predicting Device Thrombogenicity in Preclinical Animal Validation Studies: A Perspective from a Translational Research LaboratoryGreg Kaluza, Skirball Center for Cardiovascular Research
3:05–3:20 pmBreak 
3:20–3:40 pmThrombogenicity of Mechanical Circulatory Support Devices: Experience and Challenges from Design to Clinical UseZhongjun (Jon) Wu, University of Maryland
3:40–4:45 pmPanel Discussion 
4:45–5:00 pmRecap and Potential Future EffortsAnchal Kaushiva, FDA

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Pre-workshop Assignment

Please download this pre-workshop assignment to use as a reference during the workshop.

Panel Questions

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Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact: Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142,

For questions regarding workshop content please contact:

Anchal Kaushiva, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-6330,; or

James Kleinedler, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-9448,

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