§900.21. Application for approval as a certification agency. — Inbound Citations

(zz) Certification agency means a State that has been approved by FDA under § 900.21 to certify mammography facilities.

(i) A certification agency shall obtain FDA authorization for any changes it proposes to make in any standard that FDA has previously accepted under § 900.21 before requiring facilities to comply with the changes as a condition of obtaining or maintaining certification.

(b) A facility that has been denied certification is entitled to an appeals process from the certification agency. The appeals process shall be specified in writing by the certification agency and shall have been approved by FDA in accordance with §§ 900.21 and 900.22.

(a) The certification agency shall establish and implement measures that FDA has approved in accordance with § 900.21(b) to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the certification agency's behalf.

FDA shall evaluate annually the performance of each certification agency. The evaluation shall include the use of performance indicators that address the adequacy of program performance in certification, inspection, and enforcement activities. FDA will also consider any additional information deemed relevant by FDA that has been provided by the certification body or other sources or has been required by FDA as part of its oversight mandate. The evaluation also shall include a review of any changes in the standards or procedures in the areas listed in §§ 900.21(b) and 900.22 that have taken place since the original application or the last evaluation, whichever is most recent. The evaluation shall include a determination of whether there are major deficiencies in the certification agency's regulations or performance that, if not corrected, would warrant withdrawal of the approval of the certification agency under the provisions of § 900.24, or minor deficiencies that would require corrective action.