Radiation-Emitting Products

Appeal of Adverse Accreditation or Reaccreditation Decisions That Preclude Certification or Recertification

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Citation:

900.15(d)(3)(4)(5)(6): (d) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body’s appeal process is entitled to further appeal in accordance with procedures set forth in this section and in regulations published in 42 CFR part 498.

(3)  In accordance with the procedures set forth in subpart B of 42 CFR part 498, a facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision from DMQRP (Division of Mammography Quality and Radiation Programs).

(i) A facility must request reconsideration by DMQRP within 60 days of the accreditation body’s adverse appeals decision, at the following address: Division of Mammography Quality and Radiation Programs (HFZ-240), Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Attn: Inspection Compliance Branch.

(ii) The request for reconsideration shall include three copies of the following records:

(A) The accreditation body’s original denial of accreditation.

(B) All information the facility submitted to the accreditation body as part of the appeals process;

(C) A copy of the accreditation body’s adverse appeals decision; and

(D) A statement of the basis for the facility’s disagreement with the accreditation body’s decision.

(iii) DMQRP will conduct its reconsideration in accordance with the procedures set forth in subpart B of 42 CFR part 498.

(4) A facility that is dissatisfied with DMQRP’s decision following reconsideration is entitled to a formal hearing in accordance with procedures set forth in subpart D of 42 CFR part 498.

(5) Either the facility or FDA may request review of the hearing officer’s decision. Such review will be conducted by the Departmental Appeals Board in accordance with subpart E of 42 CFR part 498.

(6) A facility cannot perform mammography services while an adverse accreditation decision is being appealed.


Discussion:

A facility that has been denied accreditation is entitled to an appeal to the facility’s accreditation body (AB). A facility should avail itself of the AB's appeal process before requesting reconsideration from the Food and Drug Administration (FDA).

If the facility cannot achieve satisfactory resolution of an adverse accreditation decision through its AB's appeal process, the facility may request reconsideration of that adverse decision by FDA through the Division of Mammography Quality Standards (DMQS).

NOTE: A facility that was informed by its Certifying Agency that it must cease performing mammography cannot perform mammography services while an adverse accreditation decision is being appealed.

The appropriate procedure for requesting reconsideration of an adverse decision on accreditation is as follows:


Appeals Procedure:

A facility should make its request for reconsideration to DMQS, within 60 days of the AB's adverse appeals decision, at the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Division of Mammography Quality Standards
Attention: Program Management Branch
10903 New Hampshire Avenue
WO66-4675
Silver Spring, MD 20993
Phone: 301-796-5710
Fax: 301-847-8502

The request for reconsideration should include 3 copies of the following records:

  1. The AB's original denial of accreditation, including clinical or phantom image score sheets when applicable;

  2. All information the facility submitted to the AB as part of the appeals process, including all original films submitted to the AB (additional copies of the films are not required);

  3. A copy of the AB's adverse appeals decision including clinical or phantom image score sheets when applicable;

  4. A statement of the bases for the facility's disagreement with the AB's decision.

The DMQS will make a decision concerning the request for reconsideration within 60 days of receipt of all of the material specified above. The Division will provide the facility with written notification of its decision, and of the facility’s options as a consequence of that decision.

A facility that is dissatisfied with DMQS's decision following reconsideration is entitled to a formal hearing before the Departmental Appeals Board (DAB) of the Department of Health and Human Services. Copies of the applicable regulations (subpart D of 42 CFR part 498) for formal hearings will be supplied upon written request.

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Page Last Updated: 06/19/2014
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