StacksVerified U.S. regulatory reference

21 CFR §1.666

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Application following withdrawal. FDA will reinstate the accreditation of a third-party certification body for which it has withdrawn accreditation:
    1. (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. (2)In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under § 1.634:
      1. (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
      2. (ii)Under such conditions as FDA may impose in withdrawing accreditation.
  2. (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.