§1.1114. How does an accreditation body apply to FDA for recognition or renewal of recognition? — Inbound Citations

(a) An accreditation body that has had its recognition revoked by FDA (as described in § 1.1131) may seek reinstatement by submitting a new application for recognition under § 1.1114. The accreditation body must also submit evidence to FDA with its application to demonstrate that the issues resulting in revocation of recognition have been resolved, including evidence addressing the cause or condition of the grounds for revocation of recognition. The evidence also must identify measures that have been implemented to help ensure that such cause or condition is unlikely to recur.

(a) An accreditation body may seek reconsideration of FDA's decision to deny its application for recognition or renewal of recognition under § 1.1114, or reinstatement of recognition under § 1.1117, no later than 10 business days after the date of the issuance of such denial.

(1) 2017(E), Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies, Second edition, November 2017, IBR approved for §§ 1.1113(a) and (c), 1.1114(b), 1.1120(c), 1.1131(a).