Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&n=sp21.8.801.a&r=SUBPART&ty=HTML
Timestamp: 2020-07-11 22:05:44
Document Index: 304229600

Matched Legal Cases: ['art 801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§3', '§1271', '§1271', '§830', '§801', '§801', '§801', '§1010']

Title 21 → Chapter I → Subchapter H → Part 801 → Subpart A
§801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
§801.4 Meaning of intended uses.
§801.5 Medical devices; adequate directions for use.
§801.6 Medical devices; misleading statements.
§801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
§801.16 Medical devices; Spanish-language version of certain required statements.
§801.18 Format of dates provided on a medical device label.
(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the 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 name 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 other wording that expresses the facts.
Combination product has the meaning set forth in §3.2(e) of this chapter.
Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in §1271.3(d) of this chapter that does not meet the criteria in §1271.10(a) and that is also regulated as a device.
Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of §830.20 of this chapter. A unique device identifier is composed of:
[78 FR 58817, Sept. 24, 2013]
Link to an amendment published at 82 FR 2217, Jan. 9, 2017.
This amendment was delayed until Mar. 21, 2017, at 82 FR 9501, Feb. 7, 2017.
This amendment was further delayed until Mar. 19, 2018, at 82 FR 14319, Mar. 20, 2017.
This amendment delayed indefinitely at 83 FR 11639, Mar. 16, 2018.
The words intended uses or words of similar import in §§801.5, 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 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 advertised. 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, distributor, 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 than 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.
(c)(1)(i) All words, statements, and other information required by or under authority of the act to appear on the label or labeling for a device shall appear thereon in one or more of the following formats:
(B) In the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English;
(C) A symbol accompanied by adjacent explanatory English text, or text in the predominant language of the Territory, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English;
(D) A symbol not accompanied by adjacent explanatory text that:
(1) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the act;
(2) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and
(3) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;
(E) A symbol not accompanied by adjacent explanatory text that:
(1) Is established in a standard developed by a standards development organization (SDO);
(2) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;
(3) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the act;
(4) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and
(5) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;
(F) The symbol statement “Rx only” or “℞ only” may be used as provided under §801.109(b)(1).
(ii) The use of symbols in device labeling which do not meet the requirements of paragraph (c)(1)(i) of this section renders a device misbranded under section 502(c) of the act.
(iii) For purposes of paragraph (c)(1)(i) of this section:
(A) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.
(B) The term “symbols glossary” means a compiled listing of:
(1) Each SDO-established symbol used in the labeling for the device;
(2) The title and designation number of the SDO-developed standard containing the symbol;
(3) The title of the symbol and its reference number, if any, in the standard; and
(4) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.
[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]
If devices restricted 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).
(2) If the device is an electronic 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.