GroundRules
21 CFR 860.250: Withdrawal of a De Novo request.
Where this section sits in the code
- 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
(a) FDA considers a De Novo request to have been withdrawn if: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(4) The requester submits a written notice to FDA that the De Novo request has been withdrawn.
(b) If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.
Collected 2026-08-27T02:24:47Z. Source file · JSON