cfr_sections
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38 rows where part_number = 801 and title_number = 21 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:8.0.1.1.2.1.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. | FDA | (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 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. (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 shall 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 place 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. | ||||
| 21:21:8.0.1.1.2.1.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.3 Definitions. | FDA | [78 FR 58817, Sept. 24, 2013] | 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 the Director of the Center for Devices and Radiological Health or the Director of the Center for Biologics Evaluation and Research, depending on which Center has been assigned lead responsibility for the device. Combination product has the meaning set forth in § 3.2(e) of this chapter. Convenience kit means two or more different medical devices packaged together for the convenience of the user. Device package means a package that contains a fixed quantity of a particular version or model of a device. Expiration date means the date by which the label of a device states the device must or should be used. FDA, we, or us means the Food and Drug Administration. Finished device means any device or accessory to any device that is suitable for use or capable of functioning. Global Unique Device Identification Database (GUDID) means the database that serves as a repository of information to facilitate the identification of medical devices through their distribution and use. 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. Implantable device means a device that is intended to be placed in a surgically or naturally formed cavity of the human body. A device is regarded as an implantable device for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner of Food and Drugs determines otherwise in order to protect human health. Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act. Labeler means: … | |||
| 21:21:8.0.1.1.2.1.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.4 Meaning of intended uses. | FDA | [86 FR 41401, Aug. 2, 2021] | The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or 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. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use. 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 or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. | |||
| 21:21:8.0.1.1.2.1.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.5 Medical devices; adequate directions for use. | FDA | Adequate directions for use means directions under which the layman can use 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 device 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, uses, 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 persons 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 administration or application. (g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process. | ||||
| 21:21:8.0.1.1.2.1.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.6 Medical devices; misleading statements. | FDA | Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic. | ||||
| 21:21:8.0.1.1.2.1.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling. | FDA | [41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016] | (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 section 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 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 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, 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, or 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 insufficiency 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 of label space to give greater conspicuousness to any word, statement,… | |||
| 21:21:8.0.1.1.2.1.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.16 Medical devices; Spanish-language version of certain required statements. | FDA | 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). | ||||
| 21:21:8.0.1.1.2.1.1.9 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | A | Subpart A—General Labeling Provisions | § 801.18 Format of dates provided on a medical device label. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) In general. Whenever the label of 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 day, 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 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. | |||
| 21:21:8.0.1.1.2.2.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.20 Label to bear a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter. (2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter. (b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions. | |||
| 21:21:8.0.1.1.2.2.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013, as amended at 90 FR 55979, Dec. 4, 2025] | (a) In general. The following types of devices are excepted from the requirement of § 801.20; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI): (1) A finished device manufactured and labeled prior to the compliance date established by FDA for § 801.20 regarding the device. This exception expires with regard to a particular device 3 years after the compliance date established by FDA for the device. (2) A class I device that FDA has by regulation exempted from the good manufacturing practice requirements of part 820 of this chapter, exclusive of any continuing requirement for recordkeeping under § 820.35 of this chapter. (3) Individual single-use devices, all of a single version or model, that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution. This exception is not available for any implantable device. The device package containing these individual devices is not excepted from the requirement of § 801.20, and must bear a UDI. (4) A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use. (5) A custom device within the meaning of § 812.3(b) of this chapter. (6) An investigational device within the meaning of part 812 of this chapter. (7) A veterinary medical device not intended for use in the diagnosis of disease or other conditions in man, in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body of man. (8) A device intended for export from the United States. (9) A device held by the Strategic National Stockpile and granted an exception or alternative under § 801.128(f)(2). (10) A device for which FDA has established a performance standard under section 514(b) of the Federal Food, Drug, and Cosmetic Act and has provided therein an exception from the requirement of § 801.20, or for whic… | |||
| 21:21:8.0.1.1.2.2.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.35 Voluntary labeling of a device with a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with § 801.20. If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter. (b) A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages. | |||
| 21:21:8.0.1.1.2.2.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.40 Form of a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter. The UDI must be presented in two forms: (1) Easily readable plain-text, and (2) Automatic identification and data capture (AIDC) technology. (b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by § 1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information. (c) If the AIDC technology is not evident upon visual examination of the label or device package, the label or device package must disclose the presence of AIDC technology. (d) A class I device that bears a Universal Product Code (UPC) on its label and device packages is deemed to meet all requirements of subpart B of this part. The UPC will serve as the unique device identifier required by § 801.20. | |||
| 21:21:8.0.1.1.2.2.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.45 Devices that must be directly marked with a unique device identifier. | FDA | [78 FR 58818, Sept. 24, 2013, as amended at 90 FR 55979, Dec. 4, 2025] | (a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. (b) UDI for direct marking. The UDI provided through a direct marking on a device may be: (1) Identical to the UDI that appears on the label of the device, or (2) A different UDI used to distinguish the unpackaged device from any device package containing the device. (c) Form of a UDI when provided as a direct marking. When a device must bear a UDI as a direct marking, the UDI may be provided through either or both of the following: (1) Easily readable plain-text; (2) Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand. (d) Exceptions. The requirement of paragraph (a) of this section shall not apply to any device that meets any of the following criteria: (1) Any type of direct marking would interfere with the safety or effectiveness of the device; (2) The device cannot be directly marked because it is not technologically feasible; (3) The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use. (4) The device has been previously marked under paragraph (a) of this section. (e) Exception to be noted in design and development files. A labeler that decides to make use of an exception under paragraph (d) of this section must document the basis of that decision in the design and development files required by § 820.10(c) of this chapter. | |||
| 21:21:8.0.1.1.2.2.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.50 Labeling requirements for stand-alone software. | FDA | [78 FR 58818, Sept. 24, 2013] | (a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the version number in its production identifier. (b) Regardless of whether it is or is not distributed in packaged form, stand-alone software regulated as a medical device must provide its unique device identifier through either or both of the following: (1) An easily readable plain-text statement displayed whenever the software is started; (2) An easily readable plain-text statement displayed through a menu command (e.g., an “About * * *” command). (c) Stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier. | |||
| 21:21:8.0.1.1.2.2.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.55 Request for an exception from or alternative to a unique device identifier requirement. | FDA | [78 FR 58818, Sept. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015; 81 FR 11428, Mar. 4, 2016; 85 FR 18441, Apr. 2, 2020] | (a) A labeler may submit a request for an exception from or alternative to the requirement of § 801.20 or any other requirement of this subpart for a specified device or a specified type of device. A written request for an exception or alternative must: (1) Identify the device or devices that would be subject to the exception or alternative; (2) Identify the provisions of this subpart that are the subject of the request for an exception or alternative; (3) If requesting an exception, explain why you believe the requirements of this subpart are not technologically feasible; (4) If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of this subpart or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative; (5) Provide, if known, the number of labelers and the number of devices that would be affected if we grant the requested exception or alternative; and (6) Provide other requested information that the Center Director needs to clarify the scope and effects of the requested exception or alternative. (b) A written request for an exception or alternative must be submitted by sending it: (1) If the device is regulated by the Center for Biologics Evaluation and Research (CBER), by email to: cberudirequests@fda.hhs.gov or by correspondence to: Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993. (2) In all other cases, by email to: GUDIDSupport@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (c) The Center Director may grant an exception or alternative, either in response to a request or on his or her own initiative, if the Center Director dete… | |||
| 21:21:8.0.1.1.2.2.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | B | Subpart B—Labeling Requirements for Unique Device Identification | § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices. | FDA | [78 FR 58820, Sept. 24, 2013, as amended at 81 FR 11428, Mar. 4, 2016; 85 FR 18441, Apr. 2, 2020] | (a) On the date your device must bear a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any device package. (b) If your device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and beginning on that date, you may no longer provide an NHRIC or NDC number of the label of your device or on any device package. (c) A labeler who has been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that labeler code under a system for the issuance of UDIs, provided that — (1) Such use is consistent with the framework of the issuing agency that operates that system; and (2) No later than September 24, 2014, the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code. A request for continued use of an assigned labeler code must be submitted by email to: GUDIDSupport@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (d) Each request for continued use of an assigned labeler code must provide— (1) The name, mailing address, email address, and phone number of the labeler who is currently using the labeler code; (2) The owner/operator account identification used by the labeler to submit registration and listing information using FDA's Unified Registration and Listing System (FURLS). (3) The FDA labeler code that the labeler wants to continue using. | |||
| 21:21:8.0.1.1.2.3.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.60 Principal display panel. | FDA | The term principal display panel, as it applies to over-the-counter devices in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; and (c) In the case of any other shape of container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious “principal display panel” such as the top of a triangular or circular package, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of di… | ||||
| 21:21:8.0.1.1.2.3.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.61 Statement of identity. | FDA | (a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of the common name of the device followed by an accurate statement of the principal intended action(s) of the device. Such statement shall be placed in direct conjunction with the most prominent display of the name and shall employ terms descriptive of the principal intended action(s). The indications for use shall be included in the directions for use of the device, as required by section 502(f)(1) of the act and by the regulations in this part. (c) The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. | ||||
| 21:21:8.0.1.1.2.3.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.62 Declaration of net quantity of contents. | FDA | (a) The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size: Provided, That: (1) In the case of a firmly established general consumer usage and trade custom of declaring the quantity of a device in terms of linear measure or measure of area, such respective term may be used. Such term shall be augmented when necessary for accuracy of information by a statement of the weight, measure, or size of the individual units or of the entire device. (2) If the declaration of contents for a device by numerical count does not give accurate information as to the quantity of the device in the package, it shall be augmented by such statement of weight, measure, or size of the individual units or of the total weight, measure, or size of the device as will give such information; for example, “100 tongue depressors, adult size”, “1 rectal syringe, adult size”, etc. Whenever the Commissioner determines for a specific packaged device that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination of these does not facilitate value comparisions by consumers, he shall by regulation designate the appropriate term or terms to be used for such article. (b) Statements of weight of the contents shall be expressed in terms of avoirdupois pound and ounce. A statement of liquid measure of the contents shall be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid-ounce subdivisions thereof, and shall express the volume at 68 °F (20 °C). See also paragraph (p) of this section. (c) The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established, general consumer usage and trade custom of employing different common fractions i… | ||||
| 21:21:8.0.1.1.2.3.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Devices | § 801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. | FDA | [61 FR 20101, May 3, 1996] | (a) All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry one of the following warnings: (1) The EPA warning statement: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative statement: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) [or other class I substance, if applicable]: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT. (b) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. This provision does not replace or relieve a person from any requirements imposed under 40 CFR part 82. | |||
| 21:21:8.0.1.1.2.4.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.109 Prescription devices. | FDA | [41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016] | A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The device is: (1)(i) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or (ii) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and (2) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice. (b) The label of the device, other than surgical instruments, bears: (1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and (2) The method of its application or use. (c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which di… | ||||
| 21:21:8.0.1.1.2.4.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.110 Retail exemption for prescription devices. | FDA | A device subject to § 801.109 shall be exempt at the time of delivery to the ultimate purchaser or user from section 502(f)(1) of the act if it is delivered by a licensed practitioner in the course of his professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order. | |||||
| 21:21:8.0.1.1.2.4.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.116 Medical devices having commonly known directions. | FDA | A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual. | |||||
| 21:21:8.0.1.1.2.4.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.119 In vitro diagnostic products. | FDA | [78 FR 58820, Sept. 24, 2013] | A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in § 809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if it meets the requirements of subpart B of this part and the requirements of § 809.10 of this chapter. | ||||
| 21:21:8.0.1.1.2.4.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.122 Medical devices for processing, repacking, or manufacturing. | FDA | A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. | |||||
| 21:21:8.0.1.1.2.4.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. | FDA | A device subject to § 801.109 shall be exempt from section 502(f)(1) of this act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing. | |||||
| 21:21:8.0.1.1.2.4.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.127 Medical devices; expiration of exemptions. | FDA | (a) If a shipment or delivery, or any part thereof, of a device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device. (b) The exemptions conferred by §§ 801.119, 801.122, and 801.125 shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502(f)(1) of the act. If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by § 801.109. | |||||
| 21:21:8.0.1.1.2.4.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | D | § 801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile. | FDA | [72 FR 73601, Dec. 28, 2007, as amended at 78 FR 58820, Sept. 24, 2013] | (a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for specified lots, batches, or other units of a medical device, if the Center Director determines that compliance with such labeling requirement could adversely affect the safety, effectiveness, or availability of such devices that are or will be included in the Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores devices that are or will be included in the Strategic National Stockpile may submit, with written concurrence from a Strategic National Stockpile official, a written request for an exception or alternative described in paragraph (a) of this section to the Center Director. (ii) The Center Director may grant an exception or alternative described in paragraph (a) of this section on his or her own initiative. (2) A written request for an exception or alternative described in paragraph (a) of this section must: (i) Identify the specified lots, batches, or other units of the medical device that would be subject to the exception or alternative; (ii) Identify the labeling provision(s) listed in paragraph (f) of this section that are the subject of the exception or alternative request; (iii) Explain why compliance with the labeling provision(s) could adversely affect the safety, effectiveness, or availability of the specified lots, batches, or other units of a medical device that are or will be held in the Strategic National Stockpile; (iv) Describe any proposed safeguards or conditions that will be implemented so that the labeling of the device includes appropriate information necessary for the safe and effective use of the device, given the anticipated circumstances of use of the device; (v) Provide a draft of the proposed labeling of the specified lots, batches, or other units of the medica… | ||||
| 21:21:8.0.1.1.2.5.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | E | Subpart E—Other Exemptions | § 801.150 Medical devices; processing, labeling, or repacking. | FDA | (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of section 502(b) and (f) of the act if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such device is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such device in such establishment as will insure, if such specifications are followed, that such device will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such device from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them. (b) An exemption of a shipment or other delivery of a device under paragraph (a)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed. (c) An exemption of a shipment or other delivery of a device under paragraph (a)(2) of this section… | ||||
| 21:21:8.0.1.1.2.7.1.1 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures. | FDA | (a) The American Dental Association and leading dental authorities have advised the Food and Drug Administration of their concern regarding the safety of denture reliners, repair kits, pads, cushions, and other articles marketed and labeled for lay use in the repairing, refitting, or cushioning of ill-fitting, broken, or irritating dentures. It is the opinion of dental authorities and the Food and Drug Administration that to properly repair and properly refit dentures a person must have professional knowledge and specialized technical skill. Laymen cannot be expected to maintain the original vertical dimension of occlusion and the centric relation essential in the proper repairing or refitting of dentures. The continued wearing of improperly repaired or refitted dentures may cause acceleration of bone resorption, soft tissue hyperplasia, and other irreparable damage to the oral cavity. Such articles designed for lay use should be limited to emergency or temporary situations pending the services of a licensed dentist. (b) The Food and Drug Administration therefore regards such articles as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act, unless the labeling: (1)(i) Limits directions for use for denture repair kits to emergency repairing pending unavoidable delay in obtaining professional reconstruction of the denture; (ii) Limits directions for use for denture reliners, pads, and cushions to temporary refitting pending unavoidable delay in obtaining professional reconstruction of the denture; (2) Contains in a conspicuous manner the word “emergency” preceding and modifying each indication-for-use statement for denture repair kits and the word “temporary” preceding and modifying each indication-for-use statement for reliners, pads, and cushions; and (3) Includes a conspicuous warning statement to the effect: (i) For denture repair kits: “Warning—For emergency repairs only. Long term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This k… | ||||
| 21:21:8.0.1.1.2.7.1.2 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses. | FDA | [41 FR 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47 FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 69 FR 18803, Apr. 9, 2004] | (a) Examination of data available on the frequency of eye injuries resulting from the shattering of ordinary crown glass lenses indicates that the use of such lenses constitutes an avoidable hazard to the eye of the wearer. (b) The consensus of the ophthalmic community is that the number of eye injuries would be substantially reduced by the use in eyeglasses and sunglasses of impact-resistant lenses. (c)(1) To protect the public more adequately from potential eye injury, eyeglasses and sunglasses must be fitted with impact-resistant lenses, except in those cases where the physician or optometrist finds that such lenses will not fulfill the visual requirements of the particular patient, directs in writing the use of other lenses, and gives written notification thereof to the patient. (2) The physician or optometrist shall have the option of ordering glass lenses, plastic lenses, or laminated glass lenses made impact resistant by any method; however, all such lenses shall be capable of withstanding the impact test described in paragraph (d)(2) of this section. (3) Each finished impact-resistant glass lens for prescription use shall be individually tested for impact resistance and shall be capable of withstanding the impact test described in paragraph (d)(2) of this section. Raised multifocal lenses shall be impact resistant but need not be tested beyond initial design testing. Prism segment multifocal, slab-off prism, lenticular cataract, iseikonic, depressed segment one-piece multifocal, bioconcave, myodisc and minus lenticular, custom laminate and cemented assembly lenses shall be impact resistant but need not be subjected to impact testing. To demonstrate that all other types of impact-resistant lenses, including impact-resistant laminated glass lenses (i.e., lenses other than those described in the three preceding sentences of this paragraph (c)(3)), are capable of withstanding the impact test described in this regulation, the manufacturer of these lenses shall subject to an impact test a statistically sign… | |||
| 21:21:8.0.1.1.2.7.1.3 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.415 Maximum acceptable level of ozone. | FDA | (a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals. (b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration. (c) A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions: (1) In such a manner that it generates ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causes an accumulation of ozone in excess of 0.05 part per million by volume of air (when measured under standard conditions at 25 °C (77 °F) and 760 millimeters of mercury) in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices. This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product. (2) To generate ozone and release it into the atmosphere in hospitals or other establishments occupied by the ill or infirm. (3) To generate ozone and release it into the atmosphe… | ||||
| 21:21:8.0.1.1.2.7.1.4 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.417 Chlorofluorocarbon propellants. | FDA | [43 FR 11318, Mar. 17, 1978] | The use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in § 2.125 of this chapter. | |||
| 21:21:8.0.1.1.2.7.1.5 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.422 Prescription hearing aid labeling. | FDA | [87 FR 50755, Aug. 17, 2022] | (a) Scope. This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter. This section does not apply to group auditory trainers. (b) Definitions for the purposes of this section. This section uses the following definitions: Dispenser. A dispenser is any person, as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of hearing aids to any member of the consuming public or any employee, agent, salesperson, and/or representative of such a person. Hearing aid. A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an over-the-counter (OTC) hearing aid as defined in § 800.30 of this chapter or a hearing aid that does not satisfy the requirements in § 800.30 of this chapter. Rebuilt hearing aid. A prescription hearing aid is “rebuilt” if the manufacturer has inspected and tested the device, made any necessary modifications to ensure it meets applicable regulatory requirements, including the requirements in this section, and adequately reprocessed the device for the next user. Sale. Sale includes a lease, rental, or any other purchase or exchange for value. Used hearing aid. A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user. A hearing aid evaluation is “bona fide” if it was conducted in the p… | |||
| 21:21:8.0.1.1.2.7.1.6 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.430 User labeling for menstrual tampons. | FDA | [47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989; 55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR 52171, Aug. 25, 2004; 75 FR 20914, Apr. 22, 2010] | (a) This section applies to scented or scented deodorized menstrual tampons as identified in § 884.5460 and unscented menstrual tampons as identified in § 884.5470 of this chapter. (b) Data show that toxic shock syndrome (TSS), a rare but serious and sometimes fatal disease, is associated with the use of menstrual tampons. To protect the public and to minimize the serious adverse effects of TSS, menstrual tampons shall be labeled as set forth in paragraphs (c), (d), and (e) of this section and tested for absorbency as set forth in paragraph (f) of this section. (c) If the information specified in paragraph (d) of this section is to be included as a package insert, the following alert statement shall appear prominently and legibly on the package label: Attention: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information. Attention: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information. (d) The labeling of menstrual tampons shall contain the following consumer information prominently and legibly, in such terms as to render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use: (1)(i) Warning signs of TSS, e.g., sudden fever (usually 102° or more) and vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like a sunburn; (ii) What to do if these or other signs of TSS appear, including the need to remove the tampon at once and seek medical attention immediately; (2) The risk of TSS to all women using tampons during their menstrual period, especially the reported higher risks to women under 30 years of age and teenage girls, the estimated incidence of TSS of 1 to 17 per 100,000 menstruating women and girls per year, and the risk of death from contracting TSS; (3) The advisability of using tampons with the minimum… | |||
| 21:21:8.0.1.1.2.7.1.7 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. | FDA | [61 FR 20101, May 3, 1996] | (a)(1) All prescription and restricted device products containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall, except as provided in paragraph (b) of this section, bear the following warning statement: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. (b)(1) For prescription and restricted device products, the following alternative warning statement may be used: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) [or name of other class I substance, if applicable]: This product contains [or is manufactured with, if applicable] [ insert name of substance ], a substance which harms the environment by destroying ozone in the upper atmosphere. Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician. (2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prom… | |||
| 21:21:8.0.1.1.2.7.1.8 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.435 User labeling for latex condoms. | FDA | [62 FR 50501, Sept. 26, 1997] | (a) This section applies to the subset of condoms as identified in § 884.5300 of this chapter, and condoms with spermicidal lubricant as identified in § 884.5310 of this chapter, which products are formed from latex films. (b) Data show that the material integrity of latex condoms degrade over time. To protect the public health and minimize the risk of device failure, latex condoms must bear an expiration date which is supported by testing as described in paragraphs (d) and (h) of this section. (c) The expiration date, as demonstrated by testing procedures required by paragraphs (d) and (h) of this section, must be displayed prominently and legibly on the primary packaging (i.e., individual package), and higher levels of packaging (e.g., boxes of condoms), in order to ensure visibility of the expiration date by consumers. (d) Except as provided under paragraph (f) of this section, the expiration date must be supported by data demonstrating physical and mechanical integrity of the product after three discrete and representative lots of the product have been subjected to each of the following conditions: (1) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at 70 °C (plus or minus 2 °C) for 7 days; (2) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at a selected temperature between 40 and 50 °C (plus or minus 2 °C) for 90 days; and (3) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at a monitored or controlled temperature between 15 and 30 °C for the lifetime of the product (real time storage). (e) If a product fails the physical and mechanical integrity tests commonly used by industry after the completion of the accelerated storage tests described in par… | |||
| 21:21:8.0.1.1.2.7.1.9 | 21 | Food and Drugs | I | H | 801 | PART 801—LABELING | H | Subpart H—Special Requirements for Specific Devices | § 801.437 User labeling for devices that contain natural rubber. | FDA | [62 FR 51029, Sept. 30, 1997, as amended at 63 FR 46175, Aug. 31, 1998] | (a) Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and protect the public health. (b) This section applies to all devices composed of or containing, or having packaging or components that are composed of, or contain, natural rubber that contacts humans. The term “natural rubber” includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation. (1) The term “natural rubber latex” means rubber that is produced by the natural rubber latex process that involves the use of natural latex in a concentrated colloidal suspension. Products are formed from natural rubber latex by dipping, extruding, or coating. (2) The term “dry natural rubber” means rubber that is produced by the dry natural rubber process that involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from dry natural rubber by compression molding, extrusion, or by converting the sheets into a solution for dipping. (3) The term “contacts humans” means that the natural rubber contained in a device is intended to contact or is likely to contact the user or patient. This includes contact when the device that contains natural rubber is connected to the patient by a liquid path or an enclosed gas path; or the device containing the natural rubber is fully or partially coated with a powder, and such powder may carry natural rubber proteins that may contaminate the environment of the user or patient. (c) Devices containing natural rubber shall be labeled as set forth in paragraphs (d) through (h) of this section. Each required labeling statement shall be prominently and legibly displayed in conformance with section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352(c)). (d) Devices… |
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