§ 812.18 Import and export requirements

(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.

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What FDA inspectors cite under § 812.18

Form FDA 483 observations citing this section, fiscal years 2010–2018 (Devices).

• Exporter of investigational device 2

FDA guidance that cites § 812.18

• Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry 1 Dec 1996

Amendment history

Federal Register documents that created or amended this section.

• 45 FR 3751 18 Jan 1980
• 62 FR 26229 13 May 1997