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# Final Rule on Device Trials Conducted Outside U.S.
- URL: https://www.fdaweb.com/final-rule-on-device-trials-conducted-outside-u-s/
- Published: 2018-02-21T12:00:00.000Z
- Updated: 2026-09-14T23:24:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140806

*Federal Register* final rule: FDA has amended its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S. to support a device submission to require that such studies be conducted in accordance with good clinical practice. This includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee and obtaining and documenting freely given informed consent of subjects. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-21/pdf/2018-03244.pdf?ref=fdaweb.com).