Source: http://ecfr.io/Title-21/pt21.8.801
Timestamp: 2019-03-21 11:27:23
Document Index: 193869252

Matched Legal Cases: ['art 801', 'art 801', 'art 801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', '§801', 'art 820', '§820', '§801', '§812', '§801', '§801', '§801', '§801', '§3', '§801', '§3', '§801', 'art 830', '§830', '§1271', '§801', '§820', '§801', '§801', '§809', '§809', '§801', '§801', '§801', '§814', '§801', '§801', '§801', '§801', '§801', '§801', 'art 51', 'art 51']

[21 CFR 801] Title 21 Part 801 : Code of Federal Regulations ';
Title 21 Part 801
Title 21 → Chapter I → Subchapter H → Part 801
§801.20 Label to bear a unique device identifier.
§801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
§801.35 Voluntary labeling of a device with a unique device identifier.
§801.40 Form of a unique device identifier.
§801.45 Devices that must be directly marked with a unique device identifier.
§801.55 Request for an exception from or alternative to a unique device identifier requirement.
§801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
Subpart C—Labeling Requirements for Over-the-Counter Devices
§801.60 Principal display panel.
§801.61 Statement of identity.
§801.62 Declaration of net quantity of contents.
§801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
§801.109 Prescription devices.
§801.110 Retail exemption for prescription devices.
§801.116 Medical devices having commonly known directions.
§801.119 In vitro diagnostic products.
§801.122 Medical devices for processing, repacking, or manufacturing.
§801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
§801.127 Medical devices; expiration of exemptions.
§801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
Subpart E—Other Exemptions
§801.150 Medical devices; processing, labeling, or repacking.
(F) The symbol statement “Rx only” or “&rx; only” may be used as provided under §801.109(b)(1).
(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.
(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 §§820.180 and 820.198.
(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.
(5) A custom device within the meaning of §812.3(b) of this chapter.
(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 which FDA has recognized all or part of a performance standard under section 514(c) of the Federal Food, Drug, and Cosmetic Act and has included an exception from the requirement of §801.20 within the scope of that recognition.
(b) National Drug Code (NDC) Numbers. If a combination product properly bears an NDC number on its label—
(1) The combination product is not subject to the requirements of §801.20.
(2) A device constituent of such a combination product whose components are physically, chemically, or otherwise combined or mixed and produced as a single entity as described by §3.2(e)(1) of this chapter is not subject to the requirements of §801.20.
(3) Each device constituent of such a combination product, other than one described by §3.2(e)(1) of this chapter, must bear a UDI on its label unless paragraph (a)(11) of this section applies.
(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.
(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:
(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.
(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.
(e) Exception to be noted in design history file. 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 history file required by §820.30(j) of this chapter.
(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) If the device is regulated by the Center for Biologics Evaluation and Research (CBER), by email to: [email protected] 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: [email protected], or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
[78 FR 58818, Sept. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015; 81 FR 11428, Mar. 4, 2016]
(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: [email protected], or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
(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.
(e) The declaration shall appear as a distinct item on the principal display panel, shall be separated, by at least a space equal to the height of the lettering used in the declaration, from other printed label information appearing above or below the declaration and, by at least a space equal to twice the width of the letter “N” of the style of type used in the quantity of contents statement, from other printed label information appearing to the left or right of the declaration. It shall not include any term qualifying a unit of weight, measure, or count, such as “giant pint” and “full quart”, that tends to exaggerate. It shall be placed on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed: Provided, That:
(2) The declaration may appear in more than one line. The term “net weight” shall be used when stating the net quantity of contents in terms of weight. Use of the terms “net” or “net contents” in terms of fluid measure or numerical count is optional. It is sufficient to distinguish avoirdupois ounce from fluid ounce through association of terms; for example, “Net wt. 6 oz” or “6 oz net wt.,” and “6 fl oz” or “net contents 6 fl oz.”
(k) Examples: (1) A declaration of 11⁄2 pounds weight shall be expressed as “net wt. 24 oz (1 lb 8 oz),” or “Net wt. 24 oz (11⁄2 lb)” or “Net wt. 24 oz (1.5 lb).”
(2) A declaration of three-fourths pound avoirdupois weight shall be expressed as “Net wt. 12 oz.”.
(3) A declaration of 1 quart liquid measure shall be expressed as “Net contents 32 fl oz (1 qt)” or “32 fl oz (1 qt).”
(4) A declaration of 13⁄4 quarts liquid measure shall be expressed as, “Net contents 56 fl oz (1 qt 1 pt 8 oz)” or “Net contents 56 fl oz (1 qt 1.5 pt),” but not in terms of quart and ounce such as “Net contents 56 fl oz (1 qt 24 oz).”
(5) A declaration of 21⁄2 gallons liquid measure shall be expressed as “Net contents 2 gal 2 qt”, “Net contents 2.5 gallons,” or “Net contents 21⁄2 gal” but not as “2 gal 4 pt”.
(m) On packages labeled in terms of linear measure, the declaration shall be expressed both in terms of inches and, if applicable (1 foot or more), the largest whole units (yards, yards and feet, feet). The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of inches and any remainder shall be in terms of inches or common or decimal fractions of the foot or yard; if applicable, as in the case of adhesive tape, the initial declaration in linear inches shall be preceded by a statement of the width. Examples of linear measure are “86 inches (2 yd 1 ft 2 in)”, “90 inches (21⁄2 yd)”, “30 inches (2.5 ft)”, “ 3⁄4 inch by 36 in (1 yd)”, etc.
(n) On packages labeled in terms of area measure, the declaration shall be expressed both in terms of square inches and, if applicable (1 square foot or more), the largest whole square unit (square yards, square yards and square feet, square feet). The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of square inches and any remainder shall be in terms of square inches or common or decimal fractions of the square foot or square yard; for example, “158 sq inches (1 sq ft 14 sq in)”.
(o) Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s) describing in nondeceptive terms the net quantity of contents, provided that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the device contained in the package; for example, “giant pint” and “full quart”. Dual or combination declarations of net quantity of contents as provided for in paragraphs (a) and (i) of this section are not regarded as supplemental net quantity statements and shall be located on the principal display panel.
Note: 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]:
(1) The symbol statement “Rx only” or “&rx; 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
(d) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such 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 employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder—piece labeling which calls attention to the name of the device but does not include indications or other use information.
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.
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.
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”.
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.
(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.
(2)(i) For a Premarket Approval Application (PMA)-approved device, the submission and grant of a written request under this section satisfies the provisions relating to submission of PMA supplements under §814.39 of this chapter; however,
(1) §801.1(d);
(3) §801.60;
(4) §801.61;
(5) §801.62;
(6) §801.63;
(7) §801.109; and
[72 FR 73601, Dec. 28, 2007, as amended at 78 FR 55820, Sept. 24, 2013]
(2) Each pallet, carton, or other designated unit is conspicuously marked to show its nonsterile nature when it is introduced into and is moving in interstate commerce, and while it is being held prior to sterilization. Following sterilization, and until such time as it is established that the device is sterile and can be released from quarantine, each pallet, carton, or other designated unit is conspicuously marked to show that it has not been released from quarantine, e.g., “sterilized—awaiting test results” or an equivalent designation.
(2) In the impact test, a 5⁄8 -inch steel ball weighing approximately 0.56 ounce is dropped from a height of 50 inches upon the horizontal upper surface of the lens. The ball shall strike within a 5⁄8 -inch diameter circle located at the geometric center of the lens. The ball may be guided but not restricted in its fall by being dropped through a tube extending to within approximately 4 inches of the lens. To pass the test, the lens must not fracture; for the purpose of this section, a lens will be considered to have fractured if it cracks through its entire thickness, including a laminar layer, if any, and across a complete diameter into two or more separate pieces, or if any lens material visible to the naked eyes becomes detached from the ocular surface. The test shall be conducted with the lens supported by a tube (1-inch inside diameter, 11⁄4 -inch outside diameter, and approximately 1-inch high) affixed to a rigid iron or steel base plate. The total weight of the base plate and its rigidly attached fixtures shall be not less than 27 pounds. For lenses of small minimum diameter, a support tube having an outside diameter of less than 11⁄4 inches may be used. The support tube shall be made of rigid acrylic plastic, steel, or other suitable substance and shall have securely bonded on the top edge a 1⁄8 - by 1⁄8 -inch neoprene gasket having a hardness of 40 ±5, as determined by ASTM Method D 1415-88, “Standard Test Method for Rubber Property—International Hardness” a minimum tensile strength of 1,200 pounds, as determined by ASTM Method D 412-98A, “Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension,” and a minimum ultimate elongation of 400 percent, as determined by ASTM Method D 412-68 (Both methods are incorporated by reference and are available from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428, or available for inspection at the Center for Devices and Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 20850, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The diameter or contour of the lens support may be modified as necessary so that the 1⁄8 - by 1⁄8 -inch neoprene gasket supports the lens at its periphery.
(4) Technical data. Technical data useful in selecting, fitting, and checking the performance of a hearing aid shall be provided in the User Instructional Brochure or in separate labeling that accompanies the device. The determination of technical data values for the hearing aid labeling shall be conducted in accordance with the test procedures of the American National Standard “Specification of Hearing Aid Characteristics,” ANSI S3.22-2003 (Revision of ANSI S3.22-1996) (Includes April 2007 Erratum). The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Standards Secretariat of the Acoustical Society of America, 120 Wall St., New York, NY 10005-3993, or are available for inspection at the Regulations Staff, CDRH (HFZ-215), FDA, 1350 Piccard Dr., rm. 150, Rockville, MD 20850, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. As a minimum, the User Instructional Brochure or such other labeling shall include the appropriate values or information for the following technical data elements as these elements are defined or used in such standard:
1The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the American Society for Testing and Materials International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, 610-832-9578, www.astm.org. You may inspect a copy at the FDA Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d floor, Silver Spring, MD 20993-0002, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-2139, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.