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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 801 - Labeling |
| Subpart A - General Labeling Provisions |
| § 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor. |
| § 801.3 - Definitions. |
| § 801.4 - Meaning of intended uses. |
| § 801.5 - Medical devices; adequate directions for use. |
| § 801.6 - Medical devices; misleading statements. |
| § 801.15 - Medical devices; prominence of required label statements; use of symbols in labeling. |
| § 801.16 - Medical devices; Spanish-language version of certain required statements. |
| § 801.18 - Format of dates provided on a medical device label. |
| Subpart B - Labeling Requirements for Unique Device Identification |
| § 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. |
| § 801.50 - Labeling requirements for stand-alone software. |
| § 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. |
| 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. |
| § 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. |
| § 801.126 - Exemptions for cigarettes and smokeless tobacco. |
| § 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 - XXX |
| 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. |
| § 801.417 - Chlorofluorocarbon propellants. |
| § 801.420 - Hearing aid devices; professional and patient labeling. |
| § 801.421 - Hearing aid devices; conditions for sale. |
| § 801.422 - Prescription hearing aid labeling. |
| § 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. |