Radiation-Emitting Products

Since accreditation and certification are so closely linked, how will FDA or the Certifying State synchronize its certification period with a facility’s accreditation period?

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Certification is linked to the accreditation of the first mammography unit in a facility. The accreditation body notifies FDA or the Certifying State of a facility’s first unit accreditation, which is for three years. FDA or the Certifying State issues an initial MQSA certificate that is effective on the date provided by the accreditation body and expires three years from that date.

Facilities that wish to continue to lawfully provide mammography services must be reaccredited before the initial MQSA certificate expires. Certificates that are issued following the initial MQSA certificate are effective for three years. The expiration date of the subsequent MQSA certificate is three years from the expiration date of the previous certification.

If an already certified facility acquires an additional unit, that unit will take on the facility’s accreditation/certification expiration date once the unit is accredited.

Back to Accreditation and Certification Overview

Page Last Updated: 08/11/2014
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