How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?

21 C.F.R. § 1.1171
in effectEffective: 2024-07-01
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(a) Timing of request. 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. (b) Submission of request. The request to reconsider an application under paragraph (a) of this section must be signed by the accreditation body, as appropriate, or by an individual authorized to act on its behalf. The accreditation body must submit the request, together with any supporting information, to FDA in accordance with the procedures described in the notice of denial. (c) Notification of FDA's decision. After completing its review and evaluation of the request for reconsideration and any supporting information submitted pursuant to paragraph (b) of this section, FDA will notify the accreditation body of its decision to grant or deny recognition upon reconsideration.

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