[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.
https://workspaces.acrobat.com/?d=VRzNKiCa9cxuo*wU43yawA
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
workshop.
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
submissions.
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
ksullivan@xxxxxxxxxxx<mailto:ksullivan@xxxxxxxxxxx>
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