21 CFR § 230.70 - Supplements and other changes to a granted certification.

---
identifier: "/us/cfr/t21/s230.70"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 230.70 - Supplements and other changes to a granted certification."
title_number: 21
title_name: "Food and Drugs"
section_number: "230.70"
section_name: "Supplements and other changes to a granted certification."
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"
---


# 230.70 Supplements and other changes to a granted certification.

(a) The applicant must submit a supplement if any information in the certification request changes after the request has been deemed granted, including, but not limited to, the addition of a new facility manufacturing the designated medical gas, a change in contact information, or a change in the corporate name.

(b) Each supplement must include a signed, completed request for certification form with the updated information in accordance with § 230.50. The updated information must be submitted no later than 30 calendar days after the date the change occurred.