21 CFR 230.105
§ 230.105 When a submission is deemed granted.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 230.105, § 230.105 When a submission is deemed granted, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86142
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.