21 C.F.R. § 230.105

Current through October 31, 2024
Section 230.105 - [Effective 12/18/2025] 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.

21 C.F.R. §230.105

89 FR 51777 , 12/18/2025