D.C. Mun. Regs. tit. 22, r. 22-B10603

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10603 - RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES

10603.1

A study conducted outside of the United States (U.S.) submitted in support of a PMA and conducted under an IDE shall comply with 21 C.F.R. § 812. A study conducted outside of the U.S. submitted in support of a PMA and not conducted under an IDE shall comply with the provisions in § 10424, as applicable.

10603.2

The Department will accept studies submitted in support of a PMA which have been conducted outside of the U.S. and begun on or after November 19, 1986, if the data are valid and the investigator 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 affords 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.

10603.3

The Department will accept studies submitted in support of a PMA which have been conducted outside of the United States and begun before November 19, 1986, if the Department is satisfied that the data is scientifically valid and that the rights, safety, and welfare of human subjects have not been violated.

10603.4

A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under 21 C.F.R. § 812 may be approved if:

(a) The foreign data are applicable to the U.S. population and U.S. medical practice;

(b) The studies were performed by clinical investigators of recognized competence; and

(c) The data may be considered valid without the need for an on-site inspection by the Department or, if the Department considers such an inspection to be necessary, the Department can validate the data through an on-site inspection or other appropriate means.

10603.5

Applicants are encouraged to meet with the Department officials in a "pre-submission" meeting when approval based solely on foreign data will be sought.

D.C. Mun. Regs. tit. 22, r. 22-B10603

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.