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FDA to Hold Public Workshop on Methods for Thrombogenicity Testing

March 13, 2014

An April 14 FDA public workshop invites academics, industry professionals and regulators to discuss the advantages, limitations and optimization of in vitro and in vivo thrombogenicity test methods, as well as alternative in vitro tests. The discussion may stimulate new agency guidance or standards for testing, a Federal Register notice published Wednesday says.

The workshop, to be held at the agency’s White Oak, Md., campus, is intended to address concerns related to the four-hour canine thrombogenicity testing model that the FDA recommends in certain situations. The event will also address testing methods for a broad range of devices with blood contact — especially devices with cardiovascular applications.

The agency is soliciting comments on the strengths, weaknesses and optimization of in vivo thrombogenicity test methods and on methodologies for in vitro testing. Trial endpoints, correlations between results and clinical outcomes and special considerations for catheters, ventricular assist devices, bypass circuit components, stents and grafts are also up for comment.

Comments may be summited electronically via docket no. FDA-2014-N-0253 until May 14. View the notice at www.fdanews.com/ext/resources/files/03/03-13-14-ClottingWorkshop.pdf. — Lena Freund

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