CFR 21 Part 801.docx

1、CFR 21 Part 801TITLE 21-FOOD AND DRUGS CHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H-MEDICAL DEVICES PART 801 - LABELING Subpart A-General Labeling Provisions Sec. 801.4 Meaning of intended uses. The words intended uses or words of similar import in 801.5

2、, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown

3、 by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor a

4、dvertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, d

5、istributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other tha

6、n the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put. Sec. 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use

7、a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of: (a) Statements of all conditions, purposes, or uses for which such de

8、vice is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, u

9、ses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner. (b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for pe

10、rsons of different ages and different physical conditions. (c) Frequency of administration or application. (d) Duration of administration or application. (e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors. (f) Route or method of

11、administration or application. (g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process. Sec. 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a false or misleading representation

12、with respect to another device or a drug or food or cosmetic. Sec. 801.15 Medical devices; prominence of required label statements. (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by se

13、ction 502(c) of the act by reason, among other reasons, of: (1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase; (2) The failure of such word, statement, or information to appear on

14、 two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed; (3) The failure of the label to extend over the area of the container or package

15、 available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information; (4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement,

16、 design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency of label space for the placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, o

17、r information, or to any design or device; or (6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter. (b) No exemption depending on insufficienc

18、y of label space, as prescribed in regulations promulgated under section 502(b) of the act, shall apply if such insufficiency is caused by: (1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (2) The use

19、 of label space to give greater conspicuousness to any word, statement, or other information than is required by section 502(c) of the act; or (3) The use of label space for any representation in a foreign language. (c)(1) All words, statements, and other information required by or under authority o

20、f the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be

21、 substituted for English. (2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language. (3) If the labeling contains any representation in

22、 a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language. Sec. 801.16 Medical devices; Spanish-language version of certain required statements. If devices restri

23、cted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under 801.15(c). Sec. 801.18 Format of dates provided on a medical device label. (a) In general. Whenever the label o

24、f a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the d

25、ay, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.(b) Exceptions. (1) A combination product that properly bears a National Drug Code (NDC) number is not subject to the requirements of paragraph (a) of this section.(2) If the device is an e

26、lectronic product to which a standard is applicable under subchapter J of this chapter, Radiological Health, the date of manufacture shall be presented as required by 1010.3(a)(2)(ii) of this chapter.78 FR 55818, Sept. 24, 2013 Sec. 801.1 Medical devices; name and place of business of manufacturer,

27、packer or distributor. (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. (b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the

28、 case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for Company, Incorporated, etc., may be used and The may be omitted. In the case of an individual, partnership, or association, the nam

29、e under which the business is conducted shall be used. (c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, Manufactured for _, Distributed by _, or any oth

30、er wording that expresses the facts. (d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code sha

31、ll apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice). (e) If a person manufactures, packs, or distributes a device at a plac

32、e other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be distributed, unless such statement would be misleading. Sec. 801.3 Definitions. As used in this part:Automatic identification and data capture (AIDC) means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.Center Director means