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e-CFR data is current as of January 21, 2021

Title 21 → Chapter I → Subchapter H → Part 801

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

rule

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.
rule

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.
rule

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.
rule

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.
§801.127
Medical devices; expiration of exemptions.
§801.128
Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
rule

Subpart E—OTHER EXEMPTIONS

§801.150
Medical devices; processing, labeling, or repacking.
rule

Subparts F-G [Reserved]

rule

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.
§801.430
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.

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