Title 21

SECTION 1.666

1.666 How do I request reaccreditation

§ 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 FDA will reinstate the accreditation of a third-party certification body for which it has withdrawn accreditation: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(2) In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under § 1.634: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.

---