Marketing applications may be based on data from studies conducted in other countries. All device studies approved under an Investigational Device Exemption (IDE) are governed by the FDA IDE, Informed Consent, and IRB requirements, even if they include foreign sites in addition to sites in the U.S. [21 CFR 812, 21 CFR 50, 21 CFR 56] Device studies conducted solely at foreign sites are not subject to the IDE requirements.
FDA will accept a foreign clinical study involving a medical device not conducted under an IDE only if the study conforms to whichever of the following provides greater protection of the human subjects:
- the ethical principles contained in the 1983 version of the Declaration of Helsinki, or
- the laws and regulations of the country in which the research was conducted.
When foreign clinical data is used to support a marketing application, the applicant should ensure that the foreign data are applicable to the U.S. population and U.S. medical practice, that the clinical investigators have recognized competence, and that FDA can validate the data through an on-site inspection or other appropriate means, if necessary.
