10500.1 An owner or operator of an establishment not exempt under Section 510(g) of the Act or § 10512 of this chapter who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one (1) of these organizations when operations are conducted at more than one (1) establishment and there exists joint ownership and control among all the establishments. The term “device” includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under the Public Health Service Act, 42 U.S.C. § 262.

10500.2 An owner or operator of an establishment located in the District shall register its name, place of business, and all establishments, and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce. The registration and listing requirements shall pertain to any person who:

1. (a) Initiates or develops specifications for a device that is to be manufactured by a second party for commercial distribution by the person initiating specifications;
2. (b) Manufactures for commercial distribution a device either for itself or for another person. However, a person who only manufactures devices according to another person's specifications, for commercial distribution by the person initiating specifications, is not required to list those devices;
3. (c) Repackages or re-labels a device;
4. (d) Acts as an initial importer; or
5. (e) Manufactures components or accessories which are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (for example, blood filters, hemodialysis tubing) or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient (such as, a manufacturer of ophthalmic lens blanks).

10500.3 Registration or listing does not constitute an admission or agreement or determination that a product is a device within the meaning of Section 201(h) of the Act.

10500.4 Registration and listing requirements shall not pertain to any person who:

(a) Manufacturers devices for another party who both initiated the specifications and commercially distributes the device;

(b) Sterilizes devices on a contract basis for other registered facilities who commercially distributes the devices; or

(c) Acts as a wholesale distributor and who does not manufacture, repackage, process, or re-label a device.

10500.5 Owners and operators of establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products that are regulated under the Federal Food, Drug, and Cosmetic Act must register and list those human cells, tissues, and cellular and tissue-based products following the procedures set out in this chapter, instead of the procedures for registration and listing contained in this section, except that the additional listing information requirements in § 10506 remain applicable.

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