Medical Biological Defense (Op Sys Dev)
Abstract
The project supports technology refresh of fielded medical diagnostic systems and associated capabilities (e.g., assays) that contribute to the layered medical defenses against biological warfare agent threats facing U.S. Forces in the field. As well as, the upgrade and modernization of fielded medical nerve agent treatment system that contribute to the layered medical defenses against chemical warfare agent threats facing U.S. Forces in the field. Efforts in this project include: (1) Modernization Medical (MOD MED) (2) Next Generation Diagnostic System (NGDS) The MOD MED program supports improvements to fielded systems and supports post-fielding FDA requirements for devices and combination products. In FY22 two programs transition to MOD MED; (1) Alternative Autoinjector Manufacturer Capability (AUTOINJ) and (2) Next Generation Diagnostic System (NGDS). In FY22, program efforts include FDA required post-marketing commitments and requirements for combination products (AUTOINJ) and system hardware and software upgrades for fielded NGDS that are required to maintain the capability for CBR threat and infectious disease identification and FDA-cleared diagnostics in order to inform individual patient treatment and CBR situational awareness and disease surveillance. The NGDS program is a family of systems providing increments of diagnostic capabilities over time that address varied chemical, biological, and radiological (CBR) threats across the different echelons of the Combat Health Support System. The mission of the NGDS is to provide CBR threat and infectious disease identification and Food and Drug Administration (FDA) cleared diagnostics to inform individual patient treatment and CBR situational awareness and disease surveillance. NGDS 1 provides deployable and laboratory-based combat health support units with FDA cleared biological warfare agent (BWA) and infectious disease in vitro diagnostic (IVD) assays on an existing commercial diagnostic device with a well-established FDA regulatory history and pipeline of commercial non-BWA infectious disease diagnostic tests. In FY22, NGDS program efforts will be moved to the MOD MED (Project MB7) program.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2022
- Source ID
- MB7_0607384BP_7_0400_PB_2022
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (OP SYS DEV)
- Child Accomplishment: 1) NGDS 1
- Child Accomplishment: 2) MOD MED (NGDS 1) - System Upgrades & Support
- Child Accomplishment: 3) MOD MED (AUTOINJ) - Post Marketing Commitments
- Child Accomplishment: 4) MOD MED (AUTOINJ) - Regulatory
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