Public Workshop ? Hemostatic Medical Devices for Trauma Use, September 3-4, 2014

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Hemostatic Medical Devices for Trauma Use”. The purpose of the workshop is to obtain information on the current challenges and opportunities related to Hemostatic Medical Devices for use in emergency situations. Workshop participants will discuss factors that contribute to hemostatic medical device performance, reliability, and the types of studies that could potentially be used to evaluate appropriate bench testing, animal testing, bleeding severity, human factors, and clinical data collection for these products.

In advance of the workshop, CDRH invites interested stakeholders to submit protocols which describe procedures to evaluate issues (e.g., design, validation, conduct, and analysis) related to the adequacy of the above mentioned studies. Of particular interest are methods for assessing high-risk products used in non-compressible wound hemorrhage. These protocols will be reviewed by CDRH in order to determine viable solutions and paradigms for assessing the safety and effectiveness of hemostatic devices based on scientifically supported expert stakeholder opinions. Results of the review will be incorporated into the workshop for in-depth discussion and consensus, potentially leading to guidance from the Agency.

Deadline for submitting protocols has been extended to June 27, 2014.

Pending

If you wish to attend this Workshop, you must register by 4:00 p.m. on August 22, 2014. There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

 

This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on August 22, 2014. Organizations are requested to register all participants, but to view using one connection per location.