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Section 801.1
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Definitions |
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Section 801.3
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Meaning of intended uses |
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Section 801.4
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Medical devices; adequate directions for use |
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Section 801.5
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Medical devices; misleading statements |
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Section 801.6
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Medical devices; prominence of required label statements |
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Section 801.15
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Medical devices; Spanish-language version of certain required statements |
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Section 801.16
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Format of dates provided on a medical device label |
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Section 801.18
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Label to bear a unique device identifier |
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Section 801.20
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General exceptions from the requirement for the label of a device to bear a unique device identifier |
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Section 801.30
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Voluntary labeling of a device with a unique device identifier |
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Section 801.35
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Form of a unique device identifier |
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Section 801.40
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Devices that must be directly marked with a unique device identifier |
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Section 801.45
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Labeling requirements for stand-alone software |
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Section 801.50
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Request for an exception from or alternative to a unique device identifier requirement |
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Section 801.55
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Discontinuation of legacy FDA identification numbers assigned to devices |
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Section 801.57
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Principal display panel |
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Section 801.60
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Statement of identity |
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Section 801.61
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Declaration of net quantity of contents |
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Section 801.62
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Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other |
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Section 801.63
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Prescription devices |
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Section 801.109
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Retail exemption for prescription devices |
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Section 801.110
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Medical devices having commonly known directions |
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Section 801.116
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In vitro diagnostic products |
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Section 801.119
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Medical devices for processing, repacking, or manufacturing |
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Section 801.122
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Medical devices for use in teaching, law enforcement, research, and analysis |
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Section 801.125
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Medical devices; expiration of exemptions |
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Section 801.127
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Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile |
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Section 801.128
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Medical devices; processing, labeling, or repacking |
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Section 801.150
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Labeling of articles intended for lay use in the repairing and/or refitting of dentures |
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Section 801.405
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Use of impact-resistant lenses in eyeglasses and sunglasses |
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Section 801.410
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Maximum acceptable level of ozone |
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Section 801.415
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Chlorofluorocarbon propellants |
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Section 801.417
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Hearing aid devices; professional and patient labeling |
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Section 801.420
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Hearing aid devices; conditions for sale |
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Section 801.421
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User labeling for menstrual tampons |
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Section 801.430
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Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons |
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Section 801.433
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User labeling for latex condoms |
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Section 801.435
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User labeling for devices that contain natural rubber |
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Section 801.437
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What does this part cover? |