21 CFR 812.18
§ 812.18 Import and export requirements.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 812.18, § 812.18 Import and export requirements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88815
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Full text
(a) Imports. In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation.
(b) Exports. A person exporting an investigational device subject to this part shall obtain FDA's prior approval, as required by section 801(e) of the act or comply with section 802 of the act.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.