Source: http://www.emergogroup.com/resources/regulations-united-states/labeling-21-cfr-part-801
Timestamp: 2016-09-28 05:07:52
Document Index: 321318986

Matched Legal Cases: ['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', '§ 801', 'art 51']

[Code of Federal Regulations][Title 21, Volume 8][Revised as of April 1, 2014][CITE: 21CFR801]
TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H--MEDICAL DEVICESPART 801 LABELING
- Meaning of intended uses.
Medical devices; adequate directions for use.
Medical devices; misleading statements.
§ 801.16
Medical devices; Spanish-language version of certain required statements.
§ 801.18
Format of dates provided on a medical device label.
Medical devices; name and place of business of manufacturer, packer or distributor.
Label to bear a unique device identifier.
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.
Labeling requirements for stand-alone software.
Request for an exception from or alternative to a unique device identifier requirement.
§ 801.57
Discontinuation of legacy FDA identification numbers assigned to 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.
Subpart D--Exemptions From Adequate Directions for Use § 801.109
- Prescription devices.
§ 801.110
- Retail exemption for prescription devices.
§ 801.116
- Medical devices having commonly known directions.
- 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.
Subparts F-G [Reserved] Subpart H--Special Requirements for Specific Devices § 801.405
- Labeling of articles intended for lay use in the repairing and/or refitting of dentures
§ 801.410
- Use of impact-resistant lenses in eyeglasses and sunglasses.
§ 801.415
- Maximum acceptable level of ozone.
- Chlorofluorocarbon propellants
- Hearing aid devices; professional and patient labeling.
§ 801.421
- Hearing aid devices; conditions for sale.
§ 801.430
- User labeling for menstrual tampons.
§ 801.433
- Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
§ 801.435
- User labeling for latex condoms.
§ 801.437
- User labeling for devices that contain natural rubber.
Sec. 801.18 Format of dates provided on a medical device label. (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.
feet or foot ft
Subpart H--Special Requirements for Specific Devices Sec. 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
(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 a5/8-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, 1 1/4-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 1 1/4inches 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- by1/8- 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/cfr/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.
Warning to Hearing Aid Dispensers A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:
Important Notice for Prospective Hearing Aid Users Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.
children with hearing loss In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.
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/cfr/ibr-locations.html. [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]