known; whether a device that was replaced was left in the body; if the device was not left in the body, whether it was returned to the manufacturer.

(Information collection requirements approved by the Office of Management and Budget under control number 0910-0234)

§ 805.20 How to submit information.

Information shall be submitted to the registry in the form and manner required under general instructions of the Medicare program (see 42 CFR 409.19(a) and 410.64(a)).

§ 805.25 Confidentiality.

(a) FDA and HCFA will keep confidential, and will not reveal to the public, any specific information that identifies by name a recipient of any pacemaker device or lead or that would otherwise identify a specific recipient.

(b) Public disclosure of all other information under this part will be governed by the Freedom of Information Act (5 U.S.C. 552), the Privacy Act of 1974 (5 U.S.C. 552a), the Department of Health and Human Services' public information regulations (45 CFR part 5), FDA's public information regulations (21 CFR part 20), and HCFA's public information regulations (subpart B of 42 CFR part 401).

Sec.

807.30 Updating device listing information. 807.31 Additional listing information. 807.35 Notification of registrant.

807.37 Inspection of establishment registration and device listings.

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

Subpart C-Registration Procedures for Foreign Device Establishments

807.40 Establishment registration and device listing for foreign manufacturers of devices.

Subpart D-Exemptions

807.65 Exemptions for device establishments.

Subpart E-Premarket Notification Procedures 807.81 When a premarket notification submission is required.

807.85 Exemption from premarket notification.

807.87 Information required in a premarket notification submission.

807.90 Format of a premarket notification submission.

807.95 Confidentiality of information. 807.97 Misbranding by reference to premarket notification.

807.100 FDA action on a premarket notification.

AUTHORITY: Secs. 301, 501, 502, 510, 513, 515, 519, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 371, 374).

SOURCE: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

520(g) of the act and part 812 of this chapter; or

(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.

(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 distribution of imported devices; 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 involv

ing the owner or operator and/or a of the firm's establishments.

(f)Owner or operator means the co poration, subsidiary, affiliated comp ny, partnership, or proprietor direct responsible for the activities of th registering establishment.

(g) Distributor means any perso who furthers the marketing of device from the original place of mar ufacture to the person who make final delivery or sale to the ultimat consumer or user but who does not re package or otherwise change the con tainer, wrapper, or labeling of the device or device package.

(h) Any term defined in section 201 of the act shall have that meaning.

(i) Restricted device means a device for which the Commissioner, by regulation under § 801.109 of this chapter or otherwise under section 520(e) of the act, has restricted sale, distribution, or use only upon the written or oral authorization of a practitioner licensed by law to administer or use the device or upon such other conditions as the Commissioner may prescribe.

(j) Classification name means the term used by the Food and Drug Administration and its classification panels to describe a device or class of devices for purposes of classifying devices under section 513 of the act.

(k) Representative sampling of advertisements means typical advertising material that gives the promotional claims made for the device.

(1) Representative sampling of any other labeling means typical labeling material (excluding labels and package inserts) that gives the promotional claims made for the device.

(m) Material change includes any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, intended use, contraindications, warnings, or instructions for use. Changes that are not material may include graphic layouts, grammar, or correction of typographical errors which do not change the content of the labeling, changes in lot number, and, for devices where the biological

activity or known composition differs with each lot produced, the labeling containing the actual values for each lot.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978]

EFFECTIVE DATE NOTE: At 57 FR 18066, April 28, 1992, in § 807.3 paragraphs (n), (0), (p), and (q) were added effective May 28, 1992. At 57 FR 23059, June 1, 1992, the May 28, 1992 effective date was stayed until 60 days after the date of publication of a final rule in the FEDERAL REGISTER. For the convenience of the reader the new text is set forth below:

§ 807.3 Definitions.

(n) 510(k) summary (summary of safety and effectiveness) means a summary, submitted under section 513(i) of the act, of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.

(0) 510(k) statement means a statement made under section 513(i) of the act, asserting that the information in a premarket notification submission regarding safety and effectiveness that supports a finding of substantial equivalence will be made available, upon request, to the public. The information to be made available includes adverse safety and effectiveness information but excludes patient identifiers.

(p) Class III certification means a certification that the submitter of the 510(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices.

(q) Class III summary means a summary of the types of safety and effectiveness problems associated with the devices being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the types of problems to which the device is susceptible and the causes of such problems.

Subpart B-Procedures for Domestic Device Establishments

§ 807.20 Who must register and submit a device list.

(a) An owner or operator of an establishment not exempt under section 510(g) of the act or Subpart D of this

part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use is required to register and to submit listing information for those devices in commercial distribution, except that listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one 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 section 351 of the Public Health Service Act. An owner or operator is required to register its name, places of business, and all establishments and to 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) 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) 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) Repackages or relabels a device; (4) Initially distributes a device imported into the United States; or

(5) 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, e.g., 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, e.g., a manufacturer of ophthalmic lens blanks.

(b) No registration or listing fee is required. 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.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978]

§ 807.21 Times for establishment registration and device listing.

An owner or operator of an establishment entering into, or currently engaged in, an operation defined in § 807.3(c) and not currently registered shall register the establishment by October 22, 1977, and submit device listing by October 10, 1978. An owner or operator of an establishment who has not previously entered into an operation defined in § 807.3(c) shall register within 30 days after entering into such an operation and submit device listing information at that time. An owner or operator of an establishment shall update its registration information annually between November 15 and December 31 and shall update its device listing information every June and December or, at its discretion, at the time the change occurs.

[43 FR 37997, Aug. 25, 1978]

§ 807.22 How and where to register establishments and list devices.

(a) The first registration of a device establishment shall be on form FD2891 (Initial Registration of Device Establishments). Forms are obtainable on request from the Center for Devices and Radiological Health (HFZ342), Food and Drug Administration, Department of Health and Human Services, 1390 Piccard Dr., Rockville, MD 20850, or from the Food and Drug Administration district offices. Subsequent annual registration shall be accomplished on form FD-2891a (Registration of Device Establishment), which will be furnished by the Food and Drug Administration before November 15 of each year to establishments whose registration for that year was validated under § 807.35(a). The completed form shall be mailed to the above-designated address before December 31 of that year.

(b) The initial listing of devices and subsequent June and December updat

ings shall be on form FD-2892 (Medical Device Listing). Forms are obtainable upon request as described in paragraph (a) of this section. A separate form FD-2892 shall be submitted for each device or device class listed with the Food and Drug Administration. Devices having variations in physical characteristics such as size, package, shape, color, or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device. In lieu of form FD-2892, tapes for computer input or hard copy computer output may by submitted if equivalent in all elements of information as specified in form FD-2892. All formats proposed for use in lieu of form FD2892 require initial review and approval by the Food and Drug Administration.

(c) The listing obligations of the initial distributor within the United States of an imported device are satisfied as follows:

(1) For those imported devices for which the initial distributor has also initiated or developed the specifications, form FD-2892 shall be submitted and the historical file maintained by the initial distributor.

(2) For those imported devices for which the initial distributor repackages or relabels the device, form FD2892 shall be submitted and the historical file maintained by the initial distributor.

(3) The initial distributor is not required to submit a form FD-2892 for those imported devices for which such distributor did not initiate or develop the specifications for the device or repackage or relabel the device. However, the initial distributor shall submit, for each device, the name and address of the foreign manufacturer. Initial distributors shall also be prepared to submit, when requested by the Food and Drug Administration, the proprietary name, if any, and the common or usual name of each device for which they are the initial distributors.

(4) The initial distributor shall update the information required by paragraphs (c) (1), (2), and (3) of this section at the intervals specified in § 807.30.

[43 FR 37997, Aug. 25, 1978, as amended at 53 FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990]

§ 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 of imported devices and identify any other FDA registries in which the establishment is registered.

(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, or processed for commercial distribution that has not been included in any list of devices previously submitted on form FD-2892.

(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, 507, 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 which the reason for submission occurred, (iv) the date that the form FD-2892 was completed, (v) the owner's or operator's name and identification number.

(7) Labeling or other descriptive information (e.g., specification sheets or catalogs) adequate to describe the intended use of a device when the owner or operator is unable to find on the Food and Drug Administration list in the device listing package, an appropriate classification name for the device.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37998, Aug. 25, 1978]