21 CFR § 230.105 - When a submission is deemed granted.

---
identifier: "/us/cfr/t21/s230.105"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 230.105 - When a submission is deemed granted."
title_number: 21
title_name: "Food and Drugs"
section_number: "230.105"
section_name: "When a submission is deemed granted."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "230"
part_name: "CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES"
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, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360b, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1, 381."
regulatory_source: "89 FR 51777, June 18, 2024, unless otherwise noted."
cfr_part: "230"
---


# 230.105 When a submission is deemed granted.

Unless FDA makes one of the findings described in § 230.100(b) and notifies the applicant within 60 calendar days of filing that the submission is denied, the certification is deemed to be granted and the designated medical gas will be deemed to have in effect an approved application under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act, or both, as applicable, for the indications described in section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act. FDA will notify the applicant in writing.