equivalent in all elements of information as specified in form FD-2892. All formats proposed for use in lieu of form FD-2892 require initial review and approval by the Food and Drug Administration.

(c) The listing obligations of the initial importer are satisfied as follows:

(1) The initial importer is not required to submit a form FDA-2892 for those devices for which such initial importer did not initiate or develop the specifications for the device or repackage or relabel the device. However, the initial importer shall submit, for each device, the name and address of the manufacturer. Initial importers shall also be prepared to submit, when requested by FDA, the proprietary name, if any, and the common or usual name of each device for which they are the initial importers; and

(2) The initial importer shall update the information required by paragraphs (c)(1) of this section at the intervals specified in § 807.30.

[43 FR 37997, Aug. 25, 1978, as amended at 58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]

§ 807.25 Information required or requested for establishment registration and device listing.

(a) Form FD-2891 and Form FD2891(a) 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 post office ZIP Code, all trade names used by the establishment, and the business trading name of the owner or operator of such establishment.

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

(c) Each owner or operator is required to maintain a listing of all officers, directors, and partners for each establishment he registers and to furnish this information to the Food and Drug Administration upon request.

(d) Each owner or operator shall provide the name of an official correspondent who will serve as a point of contact between the Food and Drug

Administration and the establishment for matters relating to the registration of device establishments and the listing of device products. All future correspondence relating to registration, including requests for the names of partners, officers, and directors, will be directed to this official correspondent. In the event no person is designated by the owner or operator, the owner or operator of the establishment will be the official correspondent.

(e) 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 section 301(p) or any other provision of the act.

(f) Form FD-2892 is the approved form for providing the device listing information required by the act. This required information includes the following:

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

or

(2) The Code of Federal Regulations citation for any applicable standard for the device under section 514 of the act or section 358 of the Public Health Service Act.

(3) The assigned Food and Drug Administration number of the approved application for each device listed that is subject to section 505 or 515 of the act.

(4) 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.

(5) Whether the device, as labeled, is intended for distribution to and use by the general public.

(6) Other general information requested on form FD-2892, i.e., (i) 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, (ii) the reason for submission, (iii) the date on

Changes in individual ownership, corporate or partnership structure, or location of an operation defined in § 807.3(c) shall be submitted on Form FD-2891(a). This information shall be submitted within 30 days of such changes. Changes in the names of officers and/or directors of the corporation(s) shall be filed with the establishment's official correspondent and shall be provided to the Food and Drug Administration upon receipt of a written request for this information.

§ 807.30 Updating device listing information.

(a) Form FD-2892 shall be used to update device listing information. The preprinted original document number of each form FD-2892 on which the device was initially listed shall appear in block 2 on the form subsequently used to update the listing information for the device and on any correspondence related to the device.

(b) An owner or operator shall update the device listing information during each June and December or, at its discretion, at the time the change occurs. Conditions that require updating and information to be submitted for each of these updates are as follows:

(1) If an owner or operator introduces into commercial distribution a device identified with a classification name not currently listed by the owner or operator, then the owner or operator must submit form FD-2892 containing

(2) If an owner or operator discontinues commercial distribution of all devices in the same device class, i.e., with the same classification name, the owner or operator must submit form FD-2892 containing the original document number of the form FD-2892 on which the device class was initially listed, the reason for submission, the date of discontinuance, the owner or operator's name and identification number, the classification name and number, the proprietary name, and the common or usual name of the discontinued device.

(3) If commercial distribution of a discontinued device identified on a form FD-2892 filed under paragraph (b)(2) of this section is resumed, the owner or operator must submit on form FD-2892 a notice of resumption containing: the original document number of the form initially used to list that device class, the reason for submission, date of resumption, and all other information required by § 807.25(f).

(4) If one or more classification names for a previously listed device with multiple classification names has been added or deleted, the owner or operator must supply the original document number from the form FD-2892 on which the device was initially listed and a supplemental sheet identifying the names of any new or deleted classification names.

(5) Other changes to information on form FD-2892 will be updated as follows:

(i) Whenever a change occurs only in the owner or operator name (block 6) or number (block 7), e.g., whenever one company's device line is purchased by another owner or operator, it will not be necessary to supply a separate form FD-2892 for each device. In such cases, the new owner or operator must follow the procedures in §807.26 and submit a letter informing the Food and Drug Administration of the original document number from form FD-2892 on which each device was initially listed for those devices affected by the change in ownership.

(ii) The owner or operator must also submit update information whenever changes occur to the responses to the

questions in blocks 12, 12a, 13, 13a, and 14 on form FD-2892, or whenever establishment registration numbers, establishment names, and/or activities are added to or deleted from blocks 15, 16, and 17 of form FD-2892. The owner or operator must supply the original document number from the form FD-2892 on which the device was initially listed, the reason for submission, and all other information required by § 807.25(f).

(6) Updating is not required if the above information has not changed since the previously submitted list. Also, updating is not required if changes occur in proprietary names, in common or usual names (blocks 10 and 11 of form FD-2892), or to supplemental lists of unclassified components or accessories.

[43 FR 37998. Aug. 25, 1978]

§ 807.31 Additional listing information. (a) Each owner or operator shall maintain a historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing, as follows:

(1) For each device subject to section 514 or 515 of the act that is not a restricted device, a copy of all labeling for the device;

(2) For each restricted device, a copy of all labeling and advertisements for the device;

(3) For each device that is neither restricted nor subject to section 514 or 515 of the act, a copy of all labels, package inserts, and a representative sampling of any other labeling.

(b) In addition to the requirements set forth in paragraph (a) of this section, each owner or operator shall maintain in the historical file any labeling or advertisements in which a material change has been made anytime after initial listing.

(c) Each owner or operator may discard labeling and advertisements from the historical file 3 years after the date of the last shipment of a discontinued device by an owner or operator.

(d) Location of the file:

(1) Currently existing systems for maintenance of labeling and advertising may be used for the purpose of maintaining the historical file as long

as the information included in the systems fulfills the requirements of this section, but only if the labeling and advertisements are retrievable in a timely manner.

(2) The contents of the historical file may be physically located in more than one place in the establishment or in more than one establishment provided there exists joint ownership and control among all the establishments maintaining the historical file. If no joint ownership and control exists, the registered establishment must provide the Food and Drug Administration with a letter authorizing the establishment outside its control to maintain the historical file.

(3) A copy of the certification and disclosure statements as required by part 54 of this chapter shall be retained and physically located at the establishment maintaining the historical file.

(e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only upon specific request, the following information:

(1) For a device subject to section 514 or 515 of the act that is not a restricted device, a copy of all labeling for the device.

(2) For a device that is a restricted device, a copy of all labeling for the device, a representative sampling of advertisements for the device, and for good cause, a copy of all advertisements for a particular device. A request for all advertisements will, where feasible, be accompanied by an explanation of the basis for such request.

(3) For a device that is neither a restricted device, nor subject to section 514 of 515 of the act, the label and package insert for the device and a representative sampling of any other labeling for the device.

(4) For a particular device, a statement of the basis upon which the registrant has determined that the device is not subject to section 514 or 515 of the act.

(5) For a particular device, a statement of the basis upon which the registrant has determined the device is not a restricted device.

(6) For a particular device, a statement of the basis for determining that

the product is a device rather than a drug.

(7) For a device that the owner or operator has manufactured for distribution under a label other than its own, the names of all distributors for whom it has been manufactured.

[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2, 1998]

§ 807.35 Notification of registrant.

(a) The Commissioner will provide to the official correspondent, at the address listed on the form, a validated copy of Form FD-2891 or Form FD2891(a) (whichever is applicable) as evidence of registration. A permanent registration number will be assigned to each device establishment registered in accordance with these regulations.

(b) Owners and operators of device establishments who also manufacture or process blood or drug products at the same establishment shall also register with the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, as appropriate. Blood products shall be listed with the Center for Biologics Evaluation and Research, Food and Drug Administration, pursuant to part 607 of this chapter; drug products shall be listed with the Center for Drug Evaluation and Research, Food and Drug Administration, pursuant to part 207 of this chapter.

(c) Although establishment registration and device listing are required to engage in the device activities described in §807.20, validation of registration and the assignment of a device listing number in itself does not establish that the holder of the registration is legally qualified to deal in such devices and does not represent a determination by the Food and Drug Administration as to the status of any

device.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37999, Aug. 25, 1978; 53 FR 11252, Apr. 6, 1988]

§ 807.37 Inspection of establishment registration and device listings.

(a) A copy of the forms FD-2891 and FD-2891a filed by the registrant will be

available for inspection in accordance with section 510(f) of the act, at the Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, Department of Health and Human Services, 1390 Piccard Dr., Rockville, MD 20850. In addition, there will be available for inspection at each of the Food and Drug Administration district offices the same information for firms within the geographical area of such district office. Upon request, verification of registration number or location of a registered establishment will be provided.

(b)(1) The following information filed under the device listing requirements will be available for public disclosure: (i) Each form FD-2892 submitted; (ii) All labels submitted; (iii) All labeling submitted; (iv) All advertisements submitted; (v) All data or information that has already become a matter of public knowledge.

(2) Requests for device listing information identified in paragraph (b)(1) of this section should be directed to the Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, Department of Health and Human Services, 1390 Piccard Dr., Rockville, MD 20850.

(3) Requests for device listing information not identified in paragraph (b)(1) of this section shall be submitted and handled in accordance with part 20 of this chapter.

[43 FR 37999, Aug. 25, 1978, as amended at 53 FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990]

§ 807.39 Misbranding by reference to establishment registration or to registration number.

Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

Subpart C-Registration Procedures for Foreign Device Establishments

§ 807.40 Establishment

registration

and device listing for U.S. agents of foreign manufacturers of devices.

(a) Each foreign device manufacturer who exports devices into the United States shall designate a person as their U.S.-designated agent, who is responsible for:

(1) Submitting MDR reports,

(2) Submitting annual certifications, (3) Acting as the official correspondent,

(4) Submitting registration information,

(5) Submitting device listing information, and

(6) Submitting premarket notifications.

(b) The foreign manufacturer shall provide FDA with a statement of authorization for their U.S.-designate to perform MDR reporting duties under part 803 of this chapter, and to register, list, and submit premarket notifications under this part. The foreign manufacturer must provide this statement of authorization along with the name, address, and telephone number of the person initially designated, or any subsequent person designated as the U.S.designated agent, within 5 days of the initial or subsequent designation. Information shall be sent to the Center for Devices and Radiological Health, Medical Device Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 20847-3002.

(c) The U.S.-designated agent of a foreign device manufacturer that exports devices into the United States is required to register the foreign manufacturer's establishments or places of business, and to list the foreign manufacturer's devices, in accordance with subpart B of this part, unless exempt under subpart D of this part, and to submit premarket notifications in accordance with subpart E of this part. The information submitted shall be in the English language.

[60 FR 63606, Dec. 11, 1995]

EFFECTIVE DATE NOTE: At 61 FR 38347, July 23, 1996, §807.40 was stayed indefinitely.

Subpart D-Exemptions

§807.65 Exemptions for device estab

lishments.

The following classes of persons are exempt from registration in accordance with § 807.20 under the provisions of section 510(g) (1), (2), and (3) of the act, or because the Commissioner has found, under section 510(g)(4) of the act, that such registration is not necessary for the protection of the public health:

(a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part. (b) A manufacturer of devices to be used solely for veterinary purposes.

(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.

(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice.

(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating "distributed by" or "manufactured for" followed by the name of the pharmacy.

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution.

(g) [Reserved]

(h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers.

(i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived