| (1) To obtain a certification, facilities shall meet the quality standards in subsections (r) - (aa) of this section and be accredited by an FDA-approved accreditation body. In order to qualify for certification, new facilities must apply to the agency certifying body in accordance with the following requirements and to an FDA-approved accreditation body and receive acceptance of the accreditation application. If the facility chooses to be accredited by the agency accreditation body, the facility shall submit the information required in this subsection and §289.234(d) of this title. (2) Each person having a mammography machine shall submit an application in accordance with §289.226(e)(1) - (3) and (5) - (7) and (f)(4) - (5) of this title, and receive certification from the agency certifying body before beginning use of the mammography machine on humans. (3) An application for certification shall be signed by the lead interpreting physician. The signature of the applicant and the radiation safety officer (RSO) shall also be required. (4) An application for certification may contain information on multiple mammography machines. Each mammography machine must be identified by referring to the machine's manufacturer, model name, and serial number on the control panel. If this is not a new certification, the registrant shall maintain and provide proof of current accreditation. If accreditation expires before the expiration of the certification, the registrant shall submit proof of renewed status to the agency. (5) Each applicant shall submit documentation of the following: (A) personnel qualifications, including dates of licensure or certification, in accordance with subsection (r) of this section; (B) manufacturer, model name, and serial number of each mammography machine control panel; (C) evidence that a medical physicist: (i) has determined that each machine meets the equipment standards in subsection (s) of this section; (ii) has performed a survey and a mammography equipment evaluation in accordance with subsection (v)(10) and (11) of this section; and (iii) has determined that the average glandular dose for one craniocaudal-caudal view for each machine does not exceed the value in subsection (v)(5)(F) of this section; (D) self-referral program information in accordance with subsection (bb) of this section, if the facility offers self-referral mammography; and (E) items required for authorization of a mobile service operation in accordance with §289.226(g) of this title, if the facility provides a mobile service. (g) Issuance of certification and provisional certification. (1) Certification. A certification will be issued if the agency certifying body determines that an application meets the requirements of the Act and the requirements of this chapter. The certification authorizes the proposed activity in such form and contains such conditions and limitations as the agency certifying body deems appropriate or necessary. The certification may include one of the following: (A) mammography systems and facilities certification, following approval of accreditation by an FDA-approved accreditation body; or (B) certification of interventional breast radiography machines. (2) Requirements and conditions. The agency certifying body may incorporate in the certification at the time of issuance, or thereafter by amendment, such additional requirements and conditions with respect to the registrant's possession, use, and transfer of radiation machines subject to this chapter as it deems appropriate or necessary in order to: (A) minimize danger to occupational and public health and safety; (B) require additional reports and the keeping of additional records as may be appropriate or necessary; and (C) prevent loss or theft of radiation machines subject to this section. (3) Additional information. The agency certifying body may request, and the registrant shall provide, additional information after the certification has been issued to enable the agency certifying body to determine whether the certification should be modified in accordance with §289.226(r) of this title. (4) Provisional certification application. A new facility is eligible to apply for a provisional certification. The provisional certification 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 certification, a facility must meet the requirements of this chapter and submit the necessary information to an FDA-approved accreditation body. If the facility chooses to be accredited by the agency accreditation body, the facility shall submit the information required in subsection (f) of this section and §289.234(d) of this title to the agency accreditation body. (5) Issuing provisional certifications. Following the agency certifying body's receipt of the accreditation body's decision that a facility has submitted the required information, the agency certifying body may issue a provisional certification to a facility upon determination that the facility has satisfied the requirements of the Act and this chapter. A provisional certification shall be effective for up to six months from the date of issuance. A provisional certification cannot be renewed, but a facility may apply for a 90-day extension of the provisional certification. (6) Extension of provisional certification. Extension of provisional certifications shall be in accordance with the following. (A) To apply for a 90-day extension to a provisional certification, a facility shall submit to the FDA-approved accreditation body who issued the original certificate, 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. (B) The agency certifying body may issue a 90-day extension for a provisional certification upon determination that the extension meets the criteria in paragraph (4) of this subsection. (C) There can be no renewal of a provisional certification beyond the 90-day extension. (7) Reinstatement policy. A previously certified facility that has allowed its certification to expire, that has been refused a renewal of its certification by the agency certifying body, or that has had its certification suspended or revoked by the agency certifying body, may reapply to have the certification reinstated so that the facility may be considered to be a new facility and thereby be eligible for a provisional certification. (A) Unless prohibited from reinstatement under subsection (h)(5) of this section, a facility applying for reinstatement shall: (i) contact an FDA-approved accreditation body for reapplication for accreditation; (ii) fully document its history as a previously provisionally certified or certified mammography facility, including the following information: (I) name and address of the facility under which it was previously provisionally certified or certified; (II) name of previous owner/lessor; (III) facility identification number assigned to the facility under its previous certification by the FDA or the agency certifying body; and (IV) expiration date of the most recent FDA or agency provisional certification; and (iii) justify application for reinstatement of accreditation by submitting to an FDA-approved accreditation body 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 certification. (B) The agency certifying body may issue a provisional certification to the facility if the agency determines that the facility: (i) has adequately corrected, or is in the process of correcting, pertinent deficiencies; and (ii) has taken sufficient corrective action since the lapse of, denial of renewal, or revocation of its previous certification. (C) After receiving the provisional certification, the facility may lawfully perform mammography while completing the requirements for accreditation and certification. (h) Suspension or revocation of certification. (1) Except as provided in paragraph (2) of this subsection, the agency certifying body may suspend or revoke a certification issued by the agency certification body if it finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with §289.205 of this title, that the owner, operator, or any employee of the facility: (A) has been guilty of misrepresentation in obtaining the certification; (B) has failed to comply with the requirements of this chapter; Cont'd... |
