Section 22-B10517. CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) STATEMENT

10517.1A 21 U.S.C. § 360(k) statement submitted as part of a premarket notification shall state as follows:

“I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent in the firm), of (company name), I will make available all information included in this premarket notification on safety and effectiveness within thirty (30) days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information.”

 

10517.2The statement in § 10517.1 should be signed by the certifier, made on a separate page of the premarket notification submission, and be clearly identified as the "21 U.S.C. § 360(k) statement."

 

10517.3If information is requested by the public regarding the premarket notification § 10517.1, the request shall be made in writing to the certifier, whose name will be published by Department on the list of premarket notification submissions for which substantial equivalence determinations have been made.

 

10517.4Information provided to requestors will be a duplicate of the premarket notification submission, including any adverse information, but excluding all patient identifiers, trade secrets and confidential commercial information as defined in this chapter.

 

 

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).