Title 21, Part 801 — Labeling
38 sections
Section 801.1
Medical devices; name and place of business of manufacturer, packer or distributor.
Section 801.3
Definitions.
Section 801.4
Meaning of intended uses.
Section 801.5
Medical devices; adequate directions for use.
Section 801.6
Medical devices; misleading statements.
Section 801.15
Medical devices; prominence of required label statements; use of symbols in labeling.
Section 801.16
Medical devices; Spanish-language version of certain required statements.
Section 801.18
Format of dates provided on a medical device label.
Section 801.20
Label to bear a unique device identifier.
Section 801.30
General exceptions from the requirement for the label of a device to bear a unique device identifier.
Section 801.35
Voluntary labeling of a device with a unique device identifier.
Section 801.40
Form of a unique device identifier.
Section 801.45
Devices that must be directly marked with a unique device identifier.
Section 801.50
Labeling requirements for stand-alone software.
Section 801.55
Request for an exception from or alternative to a unique device identifier requirement.
Section 801.57
Discontinuation of legacy FDA identification numbers assigned to devices.
Section 801.60
Principal display panel.
Section 801.61
Statement of identity.
Section 801.62
Declaration of net quantity of contents.
Section 801.63
Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
Section 801.109
Prescription devices.
Section 801.110
Retail exemption for prescription devices.
Section 801.116
Medical devices having commonly known directions.
Section 801.119
In vitro diagnostic products.
Section 801.122
Medical devices for processing, repacking, or manufacturing.
Section 801.125
Medical devices for use in teaching, law enforcement, research, and analysis.
Section 801.127
Medical devices; expiration of exemptions.
Section 801.128
Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
Section 801.150
Medical devices; processing, labeling, or repacking.
Section 801.405
Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
Section 801.410
Use of impact-resistant lenses in eyeglasses and sunglasses.
Section 801.415
Maximum acceptable level of ozone.
Section 801.417
Chlorofluorocarbon propellants.
Section 801.422
Prescription hearing aid labeling.
Section 801.430
User labeling for menstrual tampons.
Section 801.433
Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
Section 801.435
User labeling for latex condoms.
Section 801.437
User labeling for devices that contain natural rubber.