Radiation-Emitting Products

Application for Extension of Provisional Certificate

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Citation:

900.11(b)(3)(i), (ii), (iii), and (iv): Extension of provisional certificate.

(i) To apply for a 90-day extension to a provisional certificate, a facility shall submit to its accreditation body, or other entity designated by FDA, a statement of what the facility is doing to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.

(ii)  The accreditation body shall forward the request, with its recommendation, to FDA within 2 business days after receipt.

(iii)  FDA may issue a 90-day extension for a provisional certificate upon determination that the extension meets the criteria set forth in 42 U.S.C. 263b(c)(2).

(iv)  There can be no renewal of a provisional certificate beyond the 90-day extension.

Discussion:

A facility operating under a six-month provisional MQSA certificate (including a provisional reinstatement MQSA certificate) may be eligible for a single 90-day extension to its provisional MQSA certificate. (A facility operating under a three-year MQSA certificate is not eligible for a 90-day extension.)

If the accreditation process is not completed within the six-month provisional period, a facility may apply to FDA or the Certifying State, through its accreditation body, for a 90-day extension. To be eligible for a 90-day extension, a facility should have adhered to the accreditation body’s schedule in submitting the necessary images and information (i.e., to have completed accreditation in the six month provisional period) and provide evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.

To apply for a 90-day extension, a facility should contact its accreditation body. Note: The MQSA Facility Hotline no longer answers questions related to 90-day extensions. Consult with the accreditation body on this issue.

The accreditation body will review the request and forward it, with its recommendation for or against the extension, to the FDA or the Certifying State for a decision. FDA or the Certifying State will then review the request and inform the facility and the accreditation body of its decision.

A facility that does not receive a 90-day extension must cease performing mammography when its provisional MQSA certificate expires, or when notified by FDA or the Certifying State that they are no longer certified based on the accreditation body’s denial of accreditation, whichever is first. Additionally, the facility should contact its accreditation body about how to resume the accreditation process.

Page Last Updated: 07/02/2014
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