Section 22-B10508. INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING

 

10508.1A copy of the forms FDA-2891 that the registrant files shall be available for inspection at the Department.  Upon request, verification of registration number or location of a registered establishment shall be provided.

 

10508.2The following information filed under the device listing requirements will be available for public disclosure:

(a)Each form FDA-2892 or its Department equivalent submitted;

 

(b)All labels submitted;

 

(c)All labeling submitted;

 

(d)All advertisements submitted; and

 

(e)All data or information that has already become a matter of public knowledge.
 

10508.3Requests for device listing information identified in § 10508.2 of this section shall be directed to the Department.

 

10508.4Requests for device listing information not identified in § 10508.2 shall be submitted and handled as specified in these regulations. 

 

 

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).