Lapas attēli

(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.

(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 pro

duced, the labeling containing the actual values for each lot.

(n) 510(k) summary (summary of any information respecting 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 all information in a premarket notification submission regarding safety and effectiveness will be made available within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information, as defined in $20.61 of this chapter.

(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 type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems.

(r) U.S.-designated agent means the person, residing in the United States, designated and authorized by the owner or operator of a foreign manufacturer who exports devices into the United States and 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 on behalf of the foreign manufacturer.

(8) Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user. [42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295, Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]

EFFECTIVE DATE NOTE: At 61 FR 38347, July 23, 1996, in $807.3, paragraph (r) was stayed indefinitely

Subpart B-Procedures for Domestic Device Establishments

merce. 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) Acts as an initial importer;

(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.

(6) Acts as the U.S.-designated agent as defined in 8807.3(r).

(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.

(c) Registration and listing requirements shall not pertain to any person who:

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

(2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the devices.

(3) Acts as a wholesale distributor, as defined in $ 807.3(s), and who does not manufacture, repackage, process, relabel a device.

$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 com


(42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998]

EFFECTIVE DATE NOTE 1: At 61 FR 38347, July 23, 1996, in $ 807.20, paragraph (a)(6) was stayed indefinitely.

EFFECTIVE DATE NOTE 2: At 66 FR 5466, Jan. 19, 2001, $ 807.20 was amended by revising the heading, effective Apr. 4, 2001, and adding paragraph (d), effective Jan. 21, 2003. For the convenience of the user, the added and revised text is set forth as follows:

8 807.20 Who must register and submit a de

vice list?


(d) 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, as defined in $ 1271.3(d) of this chapter, 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 with the Center for Biologics Evaluation and Research on Form FDA 3356 following the procedures set out in subpart B of part 1271 of this chapter, instead of the procedures for registration and listing contained in this part, except that the additional listing information requirements of $ 807.31 remain applicable.

8 807.21 Times for establishment reg

istration and device listing. (a) An owner or operator of an establishment who has not previously entered into an operation defined in 8 807.20 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 within 30 days after receiving registration forms from FDA. FDA will mail form FDA-2891a to the owners or operators of registered establishments according to a schedule based on the first letter of the name of the owner or operator. The schedule is as follows:

8807.22 How and where to register es

tablishments and list devices. (a) The first registration of a device establishment shall be on Form FDA2891 (Initial Registration of Device Establishment). Forms are available upon request from the Office of Compliance, Center for Devices and Radiological Health (HFZ-307), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, or from Food and Drug Administration district offices. Subsequent annual registration shall be accomplished on Form FDD-2891a (Annual Registration of Device Establishment), which will be furnished by FDA to establishments whose registration for that year was validated under $ 807.35(a). The forms will be mailed to the owner or operators of all establishments via the official correspondent in accordance with the schedule as described in $807.21(a). The completed form shall be mailed to the address designated in this paragraph 30 days after receipt from FDA.

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

[blocks in formation]

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. [13 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

quested for establishment registra

tion 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

of 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 af

fect 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.

(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 which the reason for submission occurred, (iv) the date that the form FD2892 was completed, (v) the owner's or operator's

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 appro- operator's name and identification priate classification name for the de- number, the classification name and vice.

number, the proprietary name, and the [42 FR 42526, Aug. 23, 1977, as amended at 43

common or usual name of the disconFR 37998, Aug. 25, 1978: 58 FR 46523, Sept. I, tinued device. 1993; 64 FR 404, Jan. 5, 1999)

(3) If commercial distribution of a

discontinued device identified on a $807.26 Amendments to establishment form FD-2892 filed under paragraph registration.

(bX2) of this section is resumed, the Changes in individual ownership, cor- owner or operator must submit on form porate or partnership structure, or lo- FD-2892 a notice of resumption concation of an operation defined in taining: the original document sumber 8807,3(c) shall be submitted on Form of the form initially used to list that FD-2891(a). This information shall be device class, the reason for submission, submitted within 30 days of such date of resumption, and all other inforchanges. Changes in the names of offi- mation required by $ 807.25(1). cers and/or directors of the corpora- (4) If one or more classification tion(s) shall be filed with the establish- names for a previously listed device ment's official correspondent and shall with multiple classification names has be provided to the Food and Drug Ad- been added or deleted, the owner or opministration upon receipt of a written erator must supply the original docurequest for this information.

ment number from the form FD-2892 on

which the device was initially listed 8807.30 Updating device listing infor- and a supplemental sheet identifying mation.

the names of any new or deleted classi(a) Form FD-2892 shall be used to up- fication names. date device listing information. The (5) Other changes to information on preprinted original document number form FD-2892 will be updated as folof each form FD-2892 on which the de- lows: vice was initially listed shall appear in (1) Whenever a change occurs only in block 2 on the form subsequently used the owner or operator name (block 6) to update the listing information for or number (block 7), e.g., whenever one the device and on any correspondence company's device line is purchased by related to the device.

another owner or operator, it will not (b) An owner or operator shall update be necessary to supply a separate form the device listing information during FD-2892 for each device. In such cases, each June and December or, at its dis- the new owner or operator must follow cretion, at the time the change occurs. the procedures in $807.26 and submit a Conditions that require updating and letter informing the Food and Drug Adinformation to be submitted for each of ministration of the original document these updates are as follows:

number from form FD-2892 on which (1) If an owner or operator introduces each device was initially listed for into commercial distribution a device those devices affected by the change in identified with a classification name ownership. not currently listed by the owner or (ii) The owner or operator must also operator, then the owner or operator submit update information whenever must submit form FD-2892 containing changes occur to the responses to the all the information required by questions in blocks 12, 12a, 13, 13a, and 8807.25(f).

14 on form FD-2892, or whenever estab(2) If an owner or operator discon- lishment registration numbers, estabtinues commercial distribution of all lishment names, and/or activities devices in the same device class, i.e., added to or deleted from blocks 15, 16, with the same classification name, the and 17 of form FD-2892. The owner or owner or operator must submit form operator must supply the original docFD-2892 containing the original docu- ument number from the form FD-2892 ment number of the form FD-2892 on on which the device was initially listwhich the device class was initially ed, the reason for submission, and all listed, the reason for submission, the other information required date of discontinuance, the owner or 8 807.25(1).



« iepriekšējāTurpināt »