10515. FORMAT OF A PREMARKET NOTIFICATION SUBMISSION

10515 FORMAT OF A PREMARKET NOTIFICATION SUBMISSION 10515.1 Each premarket notification submission pursuant to this chapter shall be submitted in accordance with this section. Each submission shall: Be addressed to the Department of Health, 899 North Capitol Street, NE, Washington, DC 20002; and 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: Bound into a volume or volumes, where necessary; 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). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10515