AR 40-60 governs Army medical acquisition programs, including policy, requirements, testing, funding, assemblages, and workforce management.
View AR 40-60 on armypubs.army.mil
AR 40-60 sets tenets and general policy for medical acquisition, including FDA and EPA approval, commercial products, integrated teams, and Decision Gate procedures. It also addresses requirements documentation, test and evaluation, medical assemblages, funding, and AMEDD acquisition workforce development.
Applies to: This policy applies to those acquisition programs funded by Army resources, as well as to those assigned to the Army for execution by the Assistant Secretary of Defense for Health Affairs (ASD(HA)) and funded by Defense Health Program (DHP) resources.
The AMEDD will acquire only U.S. Food and Drug Administration (FDA) or Environmental Protection Agency (EPA) approved products for Soldier use, whenever such approvals would be needed for civilian-use products. (paragraph 1-6)
Projects must be affordable, and must meet a validated military need. (paragraph 2)
Acquisition strategies will maximize use of commercial and non-developmental products and processes. (paragraph 1-6)
AOAs and CBAs will be robust assessments of alternatives, based upon current market research, and at a minimum will consider any potential commercial solutions, as well as the status quo. (paragraph 2-6)
FDA/ EPA approval, if required, is needed before conducting operational testing with military personnel. (paragraph 6-2)