Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff

Description

The FDA issued this guidance to describe the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension or revocation of certificate, and/or a patient and referring provider notification (PPN) order.

Scope & Applicability

• 21CFR900.12§ 900.12 Quality standards.

  (a) Personnel. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities:Read full regulation →

• 21CFR900.13§ 900.13 Revocation of accreditation and revocation of accreditation body approval.

  (a) FDA action following revocation of accreditation. If a facility's accreditation is revoked by an accreditation body, the agency may conduct an investigation into the reasons for the revocation. Following such investigation, the agency may determine that the facility's certificate shall no longerRead full regulation →

• 21CFR900.4§ 900.4 Standards for accreditation bodies.

  (a) Code of conduct and general responsibilities. The accreditation body shall accept the following responsibilities in order to ensure safe and accurate mammography at the facilities it accredits and shall perform these responsibilities in a manner that ensures the integrity and impartiality of accRead full regulation →

• 21CFR900.7§ 900.7 Hearings.

  (a) Opportunities to challenge final adverse actions taken by FDA regarding approval or reapproval of accreditation bodies, withdrawal of approval of accreditation bodies, or rejection of a proposed fee for accreditation shall be communicated through notices of opportunity for informal hearings in aRead full regulation →

• 21CFR900.15§ 900.15 Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.

  (a) The appeals procedures described in this section are available only for adverse accreditation or reaccreditation decisions that preclude certification or recertification by FDA. Agency decisions to suspend or revoke certificates that are already in effect will be handled in accordance with § 900Read full regulation →

• 21CFR10.75§ 10.75 Internal agency review of decisions.

  (a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →

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