§ 860.250. Withdrawal of a De Novo request.
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/us/cfr/t21/s§ 860.250·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)FDA considers a De Novo request to have been withdrawn if: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(4)The requester submits a written notice to FDA that the De Novo request has been withdrawn.
(b)If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.