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Application for a Provisional Certificate

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Citation

900.11(b)(2)(i) and (ii): Provisional certificates.

(i)  A new facility beginning operation after October 1, 1994, is eligible to apply for a provisional certificate. The provisional certificate will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process. To apply for and receive a provisional certificate, a facility must meet the requirements of 42 U.S. C. 263b(c)(2) and submit the necessary information to an approved accreditation body or other entity designated by FDA.

(ii)  Following the agency’s receipt of the accreditation body’s decision that a facility has submitted the required information, FDA may issue a provisional certificate to a facility upon determination that the facility has satisfied the requirements of section 900.11(b)(2)(i). A provisional certificate shall be effective for up to 6 months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a 90-day extension of the provisional certificate.

Discussion

A facility that has applied for accreditation will be issued a provisional MQSA certificate by FDA or the Certifying State after the accreditation body has 1) reviewed the facility's initial application and 2) informed FDA or the Certifying State that it has accepted the facility’s application. The provisional MQSA certificate allows the facility to perform mammography lawfully for up to six months so it can complete the accreditation process. The facility cannot perform mammography until it receives its MQSA certificate or a 45 day interim notice.

During the six month provisional period, the facility must collect clinical images and other data needed for completion of the accreditation process (within the AB required timeframes) and adhere to all requirements of the AB. If the facility has not completed the accreditation process prior to the expiration of the provisional MQSA certificate, it must cease performing mammography or apply for and receive reinstatement of the facility’s MQSA certificate. Alternatively, a facility that meets certain criteria may qualify for a one-time 90-day extension of the provisional MQSA certificate. Contact your AB for further information regarding reinstatement or a 90-day extension of the MQSA certificate.

Facilities Waiting for Receipt of their Provisional (6 month) MQSA Certificate (New Facilities)

When the AB accepts the facility’s application for review, the AB will notify FDA or the Certifying State. The Certifying Agency will fax the facility an MQSA provisional certificate or a 45 day interim notice allowing it to begin performing mammography as soon as possible. The facility cannot perform mammography until it receives either of these documents. Facilities with questions about their accreditation/certification status should first contact their AB to see if their application has been accepted and if the Certifying Agency has been notified. If the facility still has not received its MQSA certificate or interim notice, the facility should contact FDA or the Certifying State. FDA may be contacted by fax at 1-410-290-6351 or by phone at 1-800-838-7715. Contact the Certifying State if your MQSA certificate is issued by the State.