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Clinical Studies
Investigational Device Exemption (§812)
Clinical studies on human subjects that is conducted within the United States and U.S. territories must comply with Good Clinical Practices regulations. These regulations include Investigation Device Exemption (IDE) under 21 CFR 812, Protection of Human Subjects under 21 CFR 50, and Institutional Review Boards under 21 CFR 56. Guidance on these requirements can be found on the CDRH website at www.fda.gov/cdrh/devadvice/ide/index.shtml
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Research conducted outside the United States (§814.15)
A study conducted under an investigational device exemption (IDE) outside the United States and submitted in support of a PMA must comply with the IDE regulation (21 CFR 812). A study conducted outside the U.S. which was not conducted under an IDE must comply with one of the following:
Research begun on or after effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun on or after November 19, 1986, if the data constitute valid scientific evidence (§860.7) and the investigator has conducted the studies in conformance with the "Declaration of Helsinki" or the laws and regulations of the country in which the research was conducted, whichever offers greater protection to the human subjects. If the standards of the country are used, the applicant must state in detail any differences between those standards and the Declaration of Helsinki and explain why the national standards offer greater protection to the human subjects.
Research begun before effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun before November 19, 1986, if the agency is satisfied that the data constitute valid scientific evidence (§860.7) and that the rights, safety, and welfare of human subjects have not been violated.
A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:
the foreign data are applicable to the U.S. population and medical practice;
the studies have been performed by clinical investigators of recognized competence; and
the data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.
Applicants who seek approval based solely on foreign data are encouraged to meet with FDA officials in a presubmission meeting.
Additional guidance on FDA policy regarding the acceptance of foreign clinical data can be found in the following documents.
Acceptance of Foreign Clinical Studies; Guidance for Industry
www.fda.gov/cder/guidance/fstud.htm
www.fda.gov/cder/guidance/fstud.pdf
Declaration of Helsinki
www.fda.gov/oc/health/helsinki89.html
(World Medical Association’s recommendations to every physician in biomedical research involving human subjects)
www.fda.gov/cdrh/devadvice/pma/clinical_studies.html
Investigational Device Exemption (§812)
Clinical studies on human subjects that is conducted within the United States and U.S. territories must comply with Good Clinical Practices regulations. These regulations include Investigation Device Exemption (IDE) under 21 CFR 812, Protection of Human Subjects under 21 CFR 50, and Institutional Review Boards under 21 CFR 56. Guidance on these requirements can be found on the CDRH website at www.fda.gov/cdrh/devadvice/ide/index.shtml
[back to top]
Research conducted outside the United States (§814.15)
A study conducted under an investigational device exemption (IDE) outside the United States and submitted in support of a PMA must comply with the IDE regulation (21 CFR 812). A study conducted outside the U.S. which was not conducted under an IDE must comply with one of the following:
Research begun on or after effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun on or after November 19, 1986, if the data constitute valid scientific evidence (§860.7) and the investigator has conducted the studies in conformance with the "Declaration of Helsinki" or the laws and regulations of the country in which the research was conducted, whichever offers greater protection to the human subjects. If the standards of the country are used, the applicant must state in detail any differences between those standards and the Declaration of Helsinki and explain why the national standards offer greater protection to the human subjects.
Research begun before effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun before November 19, 1986, if the agency is satisfied that the data constitute valid scientific evidence (§860.7) and that the rights, safety, and welfare of human subjects have not been violated.
A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:
the foreign data are applicable to the U.S. population and medical practice;
the studies have been performed by clinical investigators of recognized competence; and
the data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.
Applicants who seek approval based solely on foreign data are encouraged to meet with FDA officials in a presubmission meeting.
Additional guidance on FDA policy regarding the acceptance of foreign clinical data can be found in the following documents.
Acceptance of Foreign Clinical Studies; Guidance for Industry
www.fda.gov/cder/guidance/fstud.htm
www.fda.gov/cder/guidance/fstud.pdf
Declaration of Helsinki
www.fda.gov/oc/health/helsinki89.html
(World Medical Association’s recommendations to every physician in biomedical research involving human subjects)
www.fda.gov/cdrh/devadvice/pma/clinical_studies.html
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