HHS - 21 CFR PART 807
ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
|Publication Date:||1 April 2016|
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following:
(1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company;
(2) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under section 520(g) of the act and part 812 of this chapter;
(3) Any distribution of a device, before the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the device is intended solely for investigational use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premarket approval application as provided in section 515 of the act; or
(4) For foreign establishments, the distribution of any device that is neither imported nor offered for import into the United States.
(c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.
(d) Manufacture, preparation, propagation, compounding, assembly, or processing of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in section 201(h) of the act. These terms include the following activities:
(1) Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;
(2) Initial importation of devices manufactured in foreign establishments; or
(3) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications.
(e) Official correspondent means the person designated by the owner or operator of an establishment as responsible for the following:
(1) The annual registration of the establishment;
(2) Contact with the Food and Drug Administration for device listing;
(3) Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner; and
(4) The receipt of pertinent correspondence from the Food and Drug Administration directed to and involving the owner or operator and/or any of the firm's establishments.
(f) Owner or operator means the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.
(g) Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.