Section 22-B10515. FORMAT OF A PREMARKET NOTIFICATION SUBMISSION

 

10515.1Each 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.

 

10515.2The 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.

 

 

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).