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.

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