FDA Medical Countermeasures Initiative Update

FDA clears military traumatic wound dressing for use in the civilian population

On December 7, 2015, FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population.

Early control of severe bleeding may prevent shock and may be life-saving. According to the United States Army Institute of Surgical Research, 30 to 40% of civilian deaths by traumatic injury are the result of hemorrhaging. Of those deaths, 33 to 56% occur before the patient reaches a hospital.
The device is available in packages of one or three syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. The sponges expand and swell to fill the wound cavity, creating a temporary physical barrier to blood flow.
Read the FDA press release

Related information

XSTAT was granted marketing authorization for battlefield use in April 2014
U.S. Army Medical Research and Materiel Command Combat Casualty Care Research Program (CCCRP)

Drug Approval Case Studies

New learning tool

FDA has introduced a new learning tool, Drug Approval Case Studies, for patients and patient advocacy groups, health professionals, small business, and pharmaceutical and clinical innovators designed to advance knowledge of drug regulatory processes.

Read FDA’s first case study in this series Drug Approval: Bringing a New Drug to the Marke t (PDF, 637 KB) to learn how to navigate the drug approval process from conducting nonclinical testing and clinical trials to submitting a new drug application to FDA.

News updates

More events:

January 6-7, 2016: PHEMCE Stakeholders Workshop 2016 - registration will close onDecember 28, 2015, or when the event reaches capacity

NEW! Public workshop - Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Silver Spring, MD and webcast) - register to attend in-person by 4:00 p.m. ET January 13, 2016. Registration is not required to view the webcast. More about cybersecurity of medical devices

February 3, 2015: Eighth Annual Sentinel Initiative Public Workshop - registration required (Washington, DC and webcast) (Federal Register notice) - more about the Sentinel Initiative

View more events on the frequently updated MCMi News and Events page

Guidance and information for industry:

December 3, 2015: Draft Guidance for Industry - Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus (PDF, 92 KB) - The draft guidance document provides blood establishments that collect blood and blood components for transfusion or further manufacture, including source plasma, with FDA recommendations for assessing blood donor suitability, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. Comment by March 2, 2016. (Federal Register notice)

December 4, 2015: Draft Guidance - Best Practices for Communication Between IND Sponsors and FDA During Drug Development (PDF, 253 KB) (Federal Register notice) - comment by February 8, 2016.

December 9, 2015: Final Guidance - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings (PDF, 319 KB) (Federal Register notice) -read more about medical gowns

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FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects

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