900.12(b)(2): General. All radiographic equipment used for mammography shall be specifically designed for mammography and shall be certified pursuant to 1010.2 of this chapter as meeting the applicable requirements of §1020.30 and 1020.31 of this chapter in effect at the date of manufacture.
Facilities are required to accredit all of their x-ray units used for mammography by submitting both clinical and phantom images for each such unit to the accreditation body as specified in 900.4(c)(4)(i) and 900.4(d)(4).
- Are all regulated mammography units in the facility required to be accredited and, if so, what documentation is necessary to establish that this has been done?
- Is there an exemption or "grandparenting" for equipment currently in use?
- At the time of the inspection, a mammographic unit is found to not meet one or more of the specific equipment requirements listed in 21 CFR 900.12(b) (3-10). Must the unit immediately be taken out of service?