When a certified facility purchases a new mammography unit, what steps must the facility take before the unit can be used for mammography?
In an already certified facility, a newly installed unit can be used only after a mammography equipment evaluation has been conducted and the requirements of the accreditation body are satisfied. 21 C.F.R. 900.12(e)(10), 900.4(e). The facility needs to immediately contact its accreditation body and follow its guidelines for newly installed mammography units before use on patients. After the new unit meets all the specified requirements, it may be used on patients and to make the clinical images needed for review by the accreditation body.