D.C. Municipal Regulations (Last Updated: September 13, 2017) |
Title 22. HEALTH |
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
Chapter 22-B109. INVESTIGATIONAL DEVICE EXEMPTIONS |
Section 22-B10915. DEPARTMENT OF HEALTH AND INSTITUTIONAL REVIEW BOARD APPROVAL
Latest version.
-
10915.1A sponsor shall not begin an investigation or part of an investigation until an IRB and the Department have both approved the application or supplemental application relating to the investigation or part of an investigation.
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.
source
Final Rulemaking published at 60 DCR 10252 (July 12, 2013).