21 C.F.R. PART 801--LABELING
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 801--LABELING
Subpart A--GENERAL LABELING PROVISIONS
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| Medical devices; name and place of business of manufacturer, packer or distributor.
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| Medical devices; adequate directions for use.
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| Medical devices; misleading statements.
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| Medical devices; prominence of required label statements.
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| Medical devices; Spanish-language version of certain required statements.
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Subpart B--[RESERVED]
Subpart C--LABELING REQUIREMENTS FOR OVER-THE-COUNTER DEVICES
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| Declaration of net quantity of contents.
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| Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
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Subpart D--EXEMPTIONS FROM ADEQUATE DIRECTIONS FOR USE
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| Retail exemption for prescription devices.
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| Medical devices having commonly known directions.
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| In vitro diagnostic products.
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| Medical devices for processing, repacking, or manufacturing.
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| Medical devices for use in teaching, law enforcement, research, and analysis.
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| Medical devices; expiration of exemptions.
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Subpart E--OTHER EXEMPTIONS
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| Medical devices; processing, labeling, or repacking.
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Subparts F-G--[RESERVED]
Subpart H--SPECIAL REQUIREMENTS FOR SPECIFIC DEVICES
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| Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
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| Use of impact-resistant lenses in eyeglasses and sunglasses.
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| Maximum acceptable level of ozone.
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| Chlorofluorocarbon propellants.
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| Hearing aid devices; professional and patient labeling.
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| Hearing aid devices; conditions for sale.
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| User labeling for menstrual tampons.
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| Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
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| User labeling for latex condoms.
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| User labeling for devices that contain natural rubber.
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