D.C. Mun. Regs. tit. 22, r. 22-B10508

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10508 - INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING

10508.1

A 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.

10508.2

The 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.

10508.3

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

10508.4

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

D.C. Mun. Regs. tit. 22, r. 22-B10508

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

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.