D.C. Mun. Regs. tit. 22-B, § 10515
Format of a Premarket Notification Submission
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
10515.1 Each premarket notification submission pursuant to this chapter shall be submitted in accordance with this section. Each submission shall:
- (a) Be addressed to the Department of Health, 899 North Capitol Street, NE, Washington, DC 20002; and
- (b) Be in writing and sent to the addresses above if it is an inquiry regarding a premarket notification submission.
10515.2 The premarket notification submission shall be:
- (a) Bound into a volume or volumes, where necessary;
- (b) Submitted in duplicate on standard size paper, including the original and two copies of the cover letter;
- (c) Submitted separately for each product the manufacturer intends to market; and
- (d) Designated "21 U.S.C. § 360(k) Notification" in the cover letter.
SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).