Mammography

Scope.

This regulation establishes the framework for FDA-approved accreditation bodies and national quality standards for mammography facilities.

Applicability.

The national quality standards for mammography apply to all facilities under U.S. jurisdiction providing mammography services, excluding the Department of Veterans Affairs.

Requirements for certification.

Mammography facilities must obtain an FDA certificate by meeting quality standards and achieving accreditation, with specific procedures for provisional certificates and reinstatement.

Quality standards.

This regulation establishes mandatory quality and safety standards for mammography services, including personnel qualifications, equipment performance, medical recordkeeping, quality assurance programs, and patient notification requirements.

Revocation of accreditation and revocation of accreditation body approval.

This provision outlines the FDA's authority to investigate and revoke a facility's mammography certificate following the loss of accreditation and the procedures for withdrawing approval of an accreditation body.

Suspension or revocation of certificates.

This provision details the grounds and procedures for the FDA to suspend or revoke a facility's mammography certificate, including notice, hearing requirements, and emergency suspension criteria.

Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.

This provision establishes the appeals process for facilities denied accreditation or reaccreditation, including the requirement to exhaust accreditation body appeals before seeking FDA reconsideration.

Appeals of denials of certification.

This provision specifies the appeals procedures for facilities that have been denied certification by the FDA after receiving accreditation from an approved body.

[Reserved]

This provision is reserved.

Alternative requirements for § 900.12 quality standards.

This provision outlines the criteria and application process for facilities, accreditation bodies, and equipment manufacturers to request approval for alternative mammography quality standards.

Definitions.

The following definitions apply to subparts A, B, and C of this part:

Scope.

This provision defines the scope of the Mammography Quality Standards Act regulations and the role of State certification agencies in ensuring compliance with national quality standards.

Application for approval as a certification agency.

This provision outlines the eligibility requirements and application process for state agencies seeking FDA approval to act as mammography certification agencies.

Standards for certification agencies.

This provision establishes the operational responsibilities for certification agencies, including conflict of interest management, inspection requirements, and patient notification protocols.

Evaluation.

This provision mandates that the FDA conduct annual performance evaluations of certification agencies to ensure compliance with regulatory standards.

Withdrawal of approval.

This provision details the procedures and grounds for the FDA to withdraw approval from a certification agency due to major or minor deficiencies.

Hearings and appeals.

This provision establishes the rights of certification agencies to challenge adverse FDA actions and mandates that facilities have an appeals process for certification denials.

Application for approval as an accreditation body.

This provision outlines the application, renewal, and operational requirements for organizations seeking FDA approval to serve as accreditation bodies for mammography facilities.

Standards for accreditation bodies.

This provision establishes the operational, quality assurance, and oversight standards for accreditation bodies responsible for monitoring mammography facilities under the Mammography Quality Standards Act.

Evaluation.

The FDA performs an annual evaluation of mammography accreditation bodies to ensure performance standards are met.

Withdrawal of approval.

The FDA may withdraw approval of an accreditation body for major or minor deficiencies in performance or compliance.

Hearings.

This provision outlines the process for challenging adverse FDA accreditation decisions and facility appeals to accreditation bodies.

§§ 900.8-900.9 [Reserved]

This section is reserved.