21 CFR § 860.250 - Withdrawal of a De Novo request.

---
identifier: "/us/cfr/t21/s860.250"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 860.250 - Withdrawal of a De Novo request."
title_number: 21
title_name: "Food and Drugs"
section_number: "860.250"
section_name: "Withdrawal of a De Novo request."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "860"
part_name: "MEDICAL DEVICE CLASSIFICATION PROCEDURES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374."
regulatory_source: "43 FR 32993, July 28, 1978, unless otherwise noted."
cfr_part: "860"
---


# 860.250 Withdrawal of a De Novo request.

(a) FDA considers a De Novo request to have been withdrawn if: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(4) The requester submits a written notice to FDA that the De Novo request has been withdrawn.

(b) If a De Novo request is withdrawn, the Agency will notify the requester. The notice will include the De Novo request reference number and the date FDA considered the De Novo request withdrawn.