Section 370.40  Exemptions

a)         Mammography units used only during invasive interventions for localization or biopsy procedures are exempt from the requirements of this Part, except that such systems shall satisfy the criteria specified in Section 370.170 of this Part.

b)         Each mobile mammography facility based outside of Illinois that operates in Illinois and that has not been certified by the Agency is exempt from the requirements of Sections 370.50 and 370.60 of this Part, provided that:

1)         The mobile mammography facility is certified to perform mammography by FDA or other FDA-approved certifying agency at all times while conducting operations in Illinois; and

2)         The mobile mammography facility meets the requirements of Section 370.145 of this Part.

            AGENCY NOTE: Mobile mammography facilities exempt under this subsection (b) shall meet the standards of this Part except those Sections specifically exempted.

(Source:  Amended at 29 Ill. Reg. 20963, effective December 16, 2005)