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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Noting Change Within a Facility

Policy Guidance Help System logoDuring the course of scheduling and/or performing an inspection, you may become aware of a change within a facility (i.e., name, address, ownership, or no longer providing mammography services). Inspectors should direct facility staff to notify their Accreditation Body (AB) of this change. The AB is responsible for maintaining complete and accurate information for each facility which they accredit, and for then electronically transferring any change(s) to FDA for its use in issuing certificates and performing inspections. Inspectors should record any changed information on the Address screen under 3.0 Facility Inspections (click on Address Changes button).