D.C. Mun. Regs. tit. 22, r. 22-B10601
Current through Register Vol. 71, No. 49, December 6, 2024
10601.1The purpose of this part is to establish an efficient and thorough device review process that will:
(a) Facilitate the approval of PMAs for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and(b) Ensure the disapproval of PMAs for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval.D.C. Mun. Regs. tit. 22, r. 22-B10601
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.