Division of Regulated Activities and Compliance (DRAC)
The Division of Regulated Activities and Compliance (DRAC) is a multidisciplinary team of regulatory affairs and compliance professionals dedicated to supporting the USAMMDA mission of developing medical products for the Warfighter. The DRAC supports the TSG Sponsor's representative in the USAMRMC for the Army regarding medical materiel development and provides full-service regulatory support for TSG-sponsored products and contracted medical product development efforts throughout the DoD acquisition spectrum.
The DRAC is organized into three branches: Regulatory Operations (RO), Medical Devices and Diagnostics (MDD) and Regulatory Science.
The RO Branch provides world-class regulatory submissions, document control and medical writing support, which includes preparation, submission, storage and tracking of all Food and Drug Administration (FDA) regulated documents. All FDA Sponsor documents, including FDA submission and clinical trial master files, are maintained in an FDA-compliant electronic document management system by the RO Branch.
The MDD Branch and Regulatory Science Branch within DRAC provide expert regulatory knowledge, subject matter expertise, and strategic regulatory direction and support for USAMMDA, as well as external commands. Both the MDDand Regulatory Science Branches provide technical management of teams of Regulatory Affairs scientists who provide expert regulatory support to IPTs which includes serving as the FDA liaison, development of regulatory strategies, providing of regulatory guidance, and review of regulatory submission documents prior to submission to FDA.
The DRAC Regulatory System Manager also ensures regulatory compliance of clinical systems used in support of FDA regulated activities by overseeing validation and testing efforts of new and existing clinical research systems.