21 CFR 812.18 - Import and export requirements.

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There is 1 Update appearing in the Federal Register for 21 CFR Part 812. View below or at eCFR (GPOAccess)
§ 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 devicesubject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shallact as the sponsor of the clinical investigation, or ensure that another personacts as the agent of the foreign exporter and the sponsor of the investigation.

(b)Exports. A person exporting an investigational devicesubject 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.

[45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997]

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 812 after this date.

  • 2016-10-12; vol. 81 # 197 - Wednesday, October 12, 2016
    1. 81 FR 70339 - Medical Devices; Custom Devices; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective October 12, 2016.
      21 CFR Parts 807 and 812

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-10-12; vol. 81 # 197 - Wednesday, October 12, 2016
    1. 81 FR 70339 - Medical Devices; Custom Devices; Technical Amendment
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective October 12, 2016.
      21 CFR Parts 807 and 812