Radiation-Emitting Products

Revocation of Accreditation

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Citation:

900.13(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 longer be in effect or the agency may take whatever other action or combination of actions will best protect the public health, including the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography.

Discussion:

When a facility’s accreditation is revoked, its MQSA certificate should remain in effect unless the FDA or the Certifying State determines that the MQSA certificate shall no longer be in effect. If FDA or the Certifying State determines that the revocation of accreditation was justified, it may determine that the MQSA certificate is no longer in effect, that the facility should take corrective action, or that other action may be appropriate while the facility seeks reaccreditation.

Page Last Updated: 08/11/2014
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