Radiation-Emitting Products

Application for Reinstatement of Accreditation and Certification

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900.11(c)(1)(2)(3)(4): (c) Reinstatement policy. A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate suspended or revoked by FDA, may apply to have the certificate reinstated so that the facility may be considered to be a new facility and thereby be eligible for a provisional certificate.

(1) Unless prohibited from reinstatement under section 900.11(c)(4), a facility applying for reinstatement shall:

(i) Contact an FDA-approved accreditation body or other entity designated by FDA to determine the requirements for reapplication for accreditation;

(ii) Fully document its history as a previously provisionally certified or certified mammography facility, including the following information:

(A) Name and address of the facility under which it was previously provisionally certified or certified;

(B) Name of previous owner/lessor;

(C) FDA facility identification number assigned to the facility under its previous certification; and

(D) Expiration date of the most recent FDA provisional certificate or certificate; and

(iii) Justify application for reinstatement of accreditation by submitting to the accreditation body or other entity designated by FDA, a corrective action plan that details how the facility has corrected deficiencies that contributed to the lapse of, denial of renewal, or revocation of its certificate.

(2) FDA may issue a provisional certificate to the facility if:

(i) The accreditation body or other entity designated by FDA notifies the agency that the facility has adequately corrected, or is in the process of correcting, pertinent deficiencies; and

(ii) FDA determines that the facility has taken sufficient corrective action since the lapse of, denial of renewal, or revocation of its previous certificate.

(3) After receiving the provisional certificate, the facility may lawfully resume performing mammography services while completing the requirements for certification.

(4) If a facility’s certificate was revoked on the basis of an act described in 42 U.S.C. 263b(i)(1), no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within 2 years of the date of revocation.

Page Last Updated: 06/19/2014
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