21 C.F.R. § 1.666

Current through July 31, 2024
Section 1.666 - How do I request reaccreditation?
(a)Application following withdrawal. FDA will reinstate the accreditation of a third-party certification body for which it has withdrawn accreditation:
(1) If, in the case of direct accreditation, FDA determines, based on evidence presented by the third-party certification body, that the third-party certification body satisfies the applicable requirements of this subpart and adequate grounds for withdrawal no longer exist; or
(2) In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under § 1.634 :
(i) If the third-party certification body becomes accredited by another recognized accreditation body or by FDA through direct accreditation no later than 1 year after withdrawal of accreditation, or the original date of the expiration of accreditation, whichever comes first; or
(ii) Under such conditions as FDA may impose in withdrawing accreditation.
(b)Application following voluntary relinquishment. A third-party certification body that previously relinquished its accreditation under § 1.665 may seek accreditation by submitting a new application for accreditation under § 1.660 or, where applicable, § 1.670 .

21 C.F.R. §1.666