D.C. Mun. Regs. tit. 22-B, § 10622
Supplemental Applications
Effective Jul 12, 201360 DCR 10252Authority: 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).District of Columbia, Office of the Secretary
10622.1 After the Department’s approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMAs under § 10608, except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 10623. The timeframes for review of, and the Department’s action on, an HDE supplement are the same as those provided in § 10625 for an HDE.
SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).