TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
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.
§ 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.
§ 801.127 - 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 [Reserved]
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.