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[A2]
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Electronic Code of Federal Regulations
| e-CFR data is current as of February 20, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) 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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| Meaning of intended uses. |
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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; use of symbols in labeling. |
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| Medical devices; Spanish-language version of certain required statements. |
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| Format of dates provided on a medical device label. |
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Subpart B—LABELING REQUIREMENTS FOR UNIQUE DEVICE IDENTIFICATION
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| Label to bear a unique device identifier. |
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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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| Voluntary labeling of a device with a unique device identifier. |
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| Form of a unique device identifier. |
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| Devices that must be directly marked with a unique device identifier. |
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| Labeling requirements for stand-alone software. |
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| Request for an exception from or alternative to a unique device identifier requirement. |
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| Discontinuation of legacy FDA identification numbers assigned to devices. |
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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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| Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile. |
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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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