Loading...
eCFR Browser
Home
Search
Bookmarks
Admin
Toggle theme
JD
eCFR Structure
Browse the hierarchical structure
Loading Part...
Title 21 - Title 21
Part 801 - LABELING
0 bookmarked
Browse sections within this part
Part Information
Details about Part 801
Description
MEDICAL DEVICES - LABELING
Official eCFR Link
View on eCFR.gov
Sections in this Part
Browse sections within Part 801
39 sections
Show Bookmarked (0)
§801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.
Title 21, Part 801
§801.109 - Prescription devices.
Title 21, Part 801
§801.110 - Retail exemption for prescription devices.
Title 21, Part 801
§801.116 - Medical devices having commonly known directions.
Title 21, Part 801
§801.119 - In vitro diagnostic products.
Title 21, Part 801
§801.122 - Medical devices for processing, repacking, or manufacturing.
Title 21, Part 801
§801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.
Title 21, Part 801
§801.127 - Medical devices; expiration of exemptions.
Title 21, Part 801
§801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
Title 21, Part 801
§801.15 - Medical devices; prominence of required label statements; use of symbols in labeling.
Title 21, Part 801
§801.150 - Medical devices; processing, labeling, or repacking.
Title 21, Part 801
§801.16 - Medical devices; Spanish-language version of certain required statements.
Title 21, Part 801
§801.18 - Format of dates provided on a medical device label.
Title 21, Part 801
§801.20 - Label to bear a unique device identifier.
Title 21, Part 801
§801.3 - Definitions.
Title 21, Part 801
§801.30 - General exceptions from the requirement for the label of a device to bear a unique device identifier.
Title 21, Part 801
§801.35 - Voluntary labeling of a device with a unique device identifier.
Title 21, Part 801
§801.4 - Meaning of intended uses.
Title 21, Part 801
§801.40 - Form of a unique device identifier.
Title 21, Part 801
§801.405 - Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
Title 21, Part 801
§801.410 - Use of impact-resistant lenses in eyeglasses and sunglasses.
Title 21, Part 801
§801.415 - Maximum acceptable level of ozone.
Title 21, Part 801
§801.417 - Chlorofluorocarbon propellants.
Title 21, Part 801
§801.420 - Hearing aid devices; professional and patient labeling.
Title 21, Part 801
§801.421 - Hearing aid devices; conditions for sale.
Title 21, Part 801
§801.430 - User labeling for menstrual tampons.
Title 21, Part 801
§801.433 - Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
Title 21, Part 801
§801.435 - User labeling for latex condoms.
Title 21, Part 801
§801.437 - User labeling for devices that contain natural rubber.
Title 21, Part 801
§801.45 - Devices that must be directly marked with a unique device identifier.
Title 21, Part 801
§801.5 - Medical devices; adequate directions for use.
Title 21, Part 801
§801.50 - Labeling requirements for stand-alone software.
Title 21, Part 801
§801.55 - Request for an exception from or alternative to a unique device identifier requirement.
Title 21, Part 801
§801.57 - Discontinuation of legacy FDA identification numbers assigned to devices.
Title 21, Part 801
§801.6 - Medical devices; misleading statements.
Title 21, Part 801
§801.60 - Principal display panel.
Title 21, Part 801
§801.61 - Statement of identity.
Title 21, Part 801
§801.62 - Declaration of net quantity of contents.
Title 21, Part 801
§801.63 - Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
Title 21, Part 801
Initializing...