{"data":{"id":"us/21-cfr-860.250","jurisdiction":"us","citation":"21 CFR 860.250","heading":"Withdrawal of a De Novo request.","body":"(a) FDA considers a De Novo request to have been withdrawn if:\n(1) The requester fails to provide a complete response to a request for additional information pursuant to § 860.240(b)(1) within 180 days after the date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;\n(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;\n(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to the De Novo request; or\n(4) The requester submits a written notice to FDA that the De Novo request has been withdrawn.\n(b) If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES","Subpart D—De Novo Classification"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"490b206cb3bddb270c890d1099160e25b59f20b4f0ebd58f68b7446308d8b7e8","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-860.240","next":"us/21-cfr-860.260"},"notice":"GroundRules: Original legal text. Not legal advice."}