§ 5.85 - Authority to ensure that mammography facilities meet quality standards.

(a) The following officials are authorized to issue, renew, and extend certificates to mammography facilities under section 354(c) of the Public Health Service Act (42 U.S.C. 263b):

(1) The Director and Deputy Director for Regulations and Policy, Center for Devices and Radiological Health (CDRH).

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(b) The following officials are authorized to accept an application for a certificate under section 354(d)(1) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(c) The following officials are authorized to approve accreditation bodies to accredit mammography facilities under section 354(e)(1)(A) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(d) The following officials are authorized to ensure that accreditation bodies provide satisfactory assurances of compliance under section 354(e)(1)(C) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(e) The Director, CDRH, is authorized to promulgate regulations under which the Director may withdraw approval of accreditation bodies under section 354(e)(2) of the Public Health Service Act.

(f) The following officials are authorized to determine the applicable standards for a facility for accreditation under section 354(e)(3) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(g) The following officials are authorized to ensure that accreditation bodies make on site visits and to determine whether other measures are appropriate under section 354(e)(4)(A) and (e)(4)(B) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(h) The following officials are authorized to evaluate annually the performance of each approved accreditation body as provided by section 354(e)(6)(A) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(i) The following officials are authorized to determine the compliance of certified facilities with established standards through facility inspections as provided by section 354(g) of the Public Health Service Act:

(1) The Director and Deputy Director for Regulations and Policy, CDRH.

(2) The Director, Office of Health and Industry Programs, CDRH.

(3) The Director, Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH.

(j) The Director and Deputy Director for Regulations and Policy, CDRH, are authorized to impose sanctions under section 354(h)(1) and (h)(2) of the Public Health Service Act.

(k) The Director and Deputy Director for Regulations and Policy, CDRH, are authorized to suspend or revoke individual facility certificates under section 354(i)(1) and (i)(2)(A) of the Public Health Service Act.

(l) The Director and Deputy Director for Regulations Policy, CDRH, are authorized to compile and make available to physicians and the general public information the Director determines is useful in evaluating the performance of mammography facilities as provided by section 354(l) of the Public Health Service Act.

(m)(1) The following officials may authorize a State to carry out certification program requirements and implement quality standards under section 354(q)(1) and (q)(2) of the Public Health Service Act:

(i) The Director and Deputy Director for Regulations and Policy, CDRH.

(ii) The Director, Office of Health and Industry Programs, CDRH.

(2) The Director, CDRH, is authorized, after providing notice and opportunity for corrective action, to withdraw the approval of a State's authority to carry out certification requirements and implement quality standards under section 354(q)(4) of the Public Health Service Act.