10503.1 Form FDA-2891 and Form FDA-2891a or their Department equivalents are the approved forms for initially providing the information required by the Act and for providing annual registration, respectively. The required information includes the name and street address of the device establishment, including zip code, all trade names that the establishment uses, and the business trading name of the owner or operator of such establishment.

10503.2 The owner or operator shall identify the device activities of the establishment such as manufacturing, repackaging, or distributing devices.

10503.3 Each owner or operator is required to maintain a listing of all officers, directors, and partners for each establishment the owner or operator registers and to furnish this information to the Department upon request.

10503.4 Each owner or operator shall provide the name of an official correspondent who will serve as a point of contact between the Department and the establishment for matters relating to the registration of device establishments and the listing of device products. All correspondence relating to registration, including requests for the names of partners, officers, and directors, will be directed to the official correspondent. In the event no person is designated by the owner or operator, the owner or operator of the establishment shall be the official correspondent.

10503.5 The designation of an official correspondent does not in any manner affect the liability of the owner or operator of the establishment or any other individual under 21 U.S.C. §§ 331(p) or any other provision of the Act.

10503.6 Form FDA-2892 or its Department equivalent is the approved form for providing the device listing information required by the Act. This required information includes the following:

(a) The identification by classification name and number, proprietary name, and common or usual name of each device being manufactured, prepared, propagated, compounded, or processed for commercial distribution that has not been included in any list of devices previously submitted on form FDA-2892 or its Department equivalent;

(b) The Code of Federal Regulations citation for any applicable standard for the device under 21 U.S.C. § 360d or 42 U.S.C. §§ 263f;

(c) The Code of Federal Regulations or DOH citation for any applicable standard for the device under 21 U.S.C. §§ 360d or 42 U.S.C. §§ 263f;

1. (d) The assigned FDA number or DOH number of the approved application for each device listed that is subject to 21 U.S.C. §§ 355 or 360e;
2. (e) The name, registration number, and establishment type of every domestic or foreign device establishment under joint ownership and control of the owner or operator at which the device is manufactured, repackaged, or relabeled;
3. (f) Whether the device, as labeled, is intended for distribution to and use by the general public;
4. (g) Other general information requested on form FDA-2892 or its Department equivalent, such as:
5. (1) If the submission refers to a previously listed device, as in the case of an update, the document number from the initial listing document for the device;
6. (2) The reason for submission;
7. (3) The date on which the reason for submission occurred;
8. (4) The date that the form FDA-2892 or its Department equivalent, was completed; and
9. (5) The owner's or operator's name and identification number; and
10. (h) Labeling or other descriptive information (for example, specification sheets or catalogs) adequate to describe the intended use of a device when the owner or operator is unable to find an appropriate Department classification name for the device.

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