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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 801LABELING
 

Subpart A--General Labeling Provisions
   § 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.
   § 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.
   § 801.4 - Meaning ofintended uses.

Subpart B [Reserved]

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.

Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

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