§ 175.54 Mammography and Breast Stereotactic X-ray.
RCNY § 175.54
(a)Applicability. The requirements of this section apply to all facilities which produce, process or interpret mammograms, including breast tomosynthesis, for screening or diagnostic purposes ("mammography facility") and are in addition to, and not in substitution for, other requirements of this Article.
(b)Requirement for certification.
(1)Except for facilities holding provisional certificates as described in paragraph (2) of this subdivision, each mammography facility must have received a certificate indicating approval by the U.S. Food and Drug Administration (FDA) to provide screening and diagnostic mammography services pursuant to 21 C.F.R. § 900.11, or any successor law or regulation.
(2)A provisional certificate issued pursuant to 21 C.F.R. § 900.11, or any successor law or regulation, will be accepted in lieu of the certificate required by paragraph (1) of this subdivision for a period of no longer than 6 months from the date of issuance plus one 90 day extension.
(c)Revocation of accreditation and accrediting body approval.
(d)Breast stereotactic x-ray. Breast stereotactic x-ray units dedicated to breast biopsy procedures are exempt from subdivisions (b) and (c) of this section. Each facility must at a minimum follow testing guidelines recommended by the American College of Radiology (ACR), or follow manufacturer recommended testing at the frequency specified. At least annually, each facility must have a QMP conduct an annual assessment of each breast stereotactic x-ray unit. The latter assessment must be in the form of a report submitted to the facility and all reported non-compliance items must be corrected within 30 days. (Added City Record 4/24/2019, eff. 5/24/2019)
