[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR814.15]

[Page 127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                            Subpart A_General
 
Sec. 814.15  Research conducted outside the United States.

    (a) A study conducted outside the United States submitted in support 
of a PMA and conducted under an IDE shall comply with part 812. A study 
conducted outside the United States submitted in support of a PMA and 
not conducted under an IDE shall comply with the provisions in paragraph 
(b) or (c) of this section, as applicable.
    (b) Research begun on or after effective date. FDA will accept 
studies submitted in support of a PMA which have been conducted outside 
the United States and begun on or after November 19, 1986, if the data 
are valid 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 is conducted, whichever accords greater 
protection to the human subjects. If the standards of the country are 
used, the applicant shall state in detail any differences between those 
standards and the ``Declaration of Helsinki'' and explain why they offer 
greater protection to the human subjects.
    (c) Research begun before effective date. FDA will accept studies 
submitted in support of a PMA which have been conducted outside the 
United States and begun before November 19, 1986, if FDA is satisfied 
that the data are scientifically valid and that the rights, safety, and 
welfare of human subjects have not been violated.
    (d) As sole basis for marketing approval. A PMA based solely on 
foreign clinical data and otherwise meeting the criteria for approval 
under this part may be approved if:
    (1) The foreign data are applicable to the U.S. population and U.S. 
medical practice;
    (2) The studies have been performed by clinical investigators of 
recognized competence; and
    (3) 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.
    (e) Consultation between FDA and applicants. Applicants are 
encouraged to meet with FDA officials in a ``presubmission'' meeting 
when approval based solely on foreign data will be sought.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 
FR 43344, Dec. 2, 1986]