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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Withdrawal of Accreditation Body Approval

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Citation:

900.13(b)(1) and (2): (b) Withdrawal of FDA approval of an accreditation body.

(1) If FDA withdraws approval of an accreditation body under section 900.6, the certificates of facilities previously accredited by such body shall remain in effect for up to 1 year from the date of the withdrawal of approval, unless FDA determines, in order to protect human health or because the accreditation body fraudulently accredited facilities, that the certificates of some or all of the facilities should be revoked or suspended or that a shorter time period should be established for the certificates to remain in effect.

(2) After 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by the agency, the affected facilities must obtain accreditation from another accreditation body, or from another entity designated by FDA.

Discussion:

In the event that FDA withdraws the approval of an accreditation body, the certificates of facilities accredited by the facility should remain in effect for one year or until the facilities receive accreditation by a new body, whichever is shorter. When facilities are accredited by a new body, they should receive a new certificate reflecting the change. In the event that there is no approved accreditation body available, FDA should identify another entity that should be able to provide accreditation.