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43 FR 32993, July 28, 1978, unless otherwise noted.
86 FR 54847, Oct. 5, 2021, unless otherwise noted.
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Nomenclature changes to part 860 appear at 73 FR 35341, June 23, 2008, and at 86 FR 54846, Oct. 5, 2021.
(a) FDA considers a De Novo request to have been withdrawn if:
(1) The requester fails to provide a complete response to a request for additional information pursuant to § 860.240(b)(1) within 180 days after the date FDA issues such request;
(2) The requester fails to provide a complete response to the deficiencies identified by FDA pursuant to § 860.230(c)(2) within 180 days of the date notification was issued by FDA;
(3) The requester does not permit an authorized FDA employee an opportunity to inspect the facilities, pursuant to § 860.240(c), at a reasonable time and in a reasonable manner, and to have access to copy and verify all records pertinent to the De Novo request; or
(4) The requester submits a written notice to FDA that the De Novo request has been withdrawn.
(b) If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.