A facility moves or relocates and the address on its MQSA certificate is no longer correct. Is the MQSA certificate still valid?
Your MQSA certificate is still valid. However, when a facility moves or relocates, it must notify its accreditation body. The facility is reminded that any mammography unit or processor that is disassembled and reassembled at the same or different location must have a mammography equipment evaluation. Any failures of a regulatory requirement found during the mammography equipment evaluation must be corrected before that piece of equipment is used for patient examinations. The accreditation body will direct the facility regarding any additional information and/or testing that it may require. The accreditation body will then inform FDA or the Certifying State of the facility’s new address. FDA will no longer issue replacement certificates for address changes. At the time of the next renewal, FDA-issued MQSA certificates will be issued with the facility name only. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding replacement of MQSA certificates.