21 CFR § 230.70 Certification and Postmarketing Reporting for Designated Medical Gases

§ 230.70 Supplements and other changes to a granted certification.

Current through Sep 8, 2026 · Read all of Part 230

(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.

← § 230.65 Withdrawal by the applicant of a certification request before it is deemed granted.§ 230.72 Change in ownership of a granted certification. →