WHO MUST REPORT
a. Prepare and process a Form FDA 2579 if you had direct supervisory control
over the assembly or installation of certified, specified components by Department of
Army (DA) personnel under conditions requiring a report of assembly.
b. Prepare and process a Form FDA 2579 if you were the contractor's
representative who had direct supervisory responsibility for an assembly or installation
performed within the territorial limits of the United States.
c. Prepare and process a Form FDA 2579 if you were the senior medical
equipment repairer supervising the assembly or installation of certified X-ray diagnostic
equipment performed outside of the United States.
Civilian contractors are not bound to prepare or submit a Form FDA 2579 for
assembly or installation of any X-ray component performed outside the United
PREPARATION OF THE FOOD AND DRUG ADMINISTRATION FORM 2579
a. Section 1, Equipment Location. Refer to figure 4-2. Complete boxes "a"
through "f" listing the official name, address, and telephone number of the medical or
dental activity in which the component or diagnostic system is installed.
b. Section 2, Assembler Information. Refer to figure 4-2. Complete boxes "a"
through "f" listing the name, address, and telephone number of the equipment installer
or assembler. In the event a civilian contractor installed the equipment, that name and
address would appear here.
Figure 4-2. Sections 1 and 2.