[ascct] US FDA requests information on thrombogenic potential of devices

  • From: Kristie Sullivan <KSullivan@xxxxxxxx>
  • To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
  • Date: Thu, 7 Nov 2013 13:33:19 -0500

The U.S. Food and Drug Administration (FDA), an ICCVAM member agency, is 
coordinating an upcoming public workshop at its White Oak campus in Silver 
Spring, Maryland. The goal of the workshop is to review test methods that are 
likely to predict clinical thrombogenic potential of blood-contacting medical 
devices. Information about the workshop will be provided at a later date.

You are invited to participate in a pre-workshop assignment that will allow you 
to provide input on your current practices used for in vitro and in vivo 
thrombogenicity testing. Please complete the form "Pre-workshop 
assignment_distributed.pdf" using Adobe Acrobat or Adobe Reader by December 
6th, 2013. To open the document, click on the link below, or copy and paste 
this URL into your browser.

After the page loads, a green "Download" button will appear in the window. 
Click the button to download the form and open it using Acrobat Reader. The 
form should take approximately 30-60 minutes to complete. When you are 
finished, click "Submit" in the upper right-hand corner of the Acrobat Reader 
window to return your data. Your raw data responses will only be seen by FDA 
personnel, and the identity of all submitters will remain anonymous. The data 
will be aggregated and deidentified prior to use for developing panel sessions, 
and the compiled results will be presented to attendees of the upcoming 

Thank you for taking time out of your schedule to assist FDA. Your responses 
are extremely valuable, and may help to inform future guidance for regulatory 

If there are other contacts within your organization whom you feel would be 
appropriate recipients of this assignment, please feel free to forward this 
invitation to them.

Kristie Sullivan
Secretary, ASCCT

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