 |
|
 |
Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 801--LABELING
Subpart A--GENERAL LABELING PROVISIONS
|
| Medical devices; name and place of business of manufacturer, packer or distributor. |
|
|
| Medical devices; adequate directions for use. |
|
|
| Medical devices; misleading statements. |
|
|
| Medical devices; prominence of required label statements. |
|
|
| Medical devices; Spanish-language version of certain required statements. |
|
Subpart B--[RESERVED]
Subpart C--LABELING REQUIREMENTS FOR OVER-THE-COUNTER DEVICES
|
| Declaration of net quantity of contents. |
|
|
| 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
|
| Retail exemption for prescription devices. |
|
|
| Medical devices having commonly known directions. |
|
|
| In vitro diagnostic products. |
|
|
| Medical devices for processing, repacking, or manufacturing. |
|
|
| Medical devices for use in teaching, law enforcement, research, and analysis. |
|
|
| Medical devices; expiration of exemptions. |
|
|
| Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile. |
|
Subpart E--OTHER EXEMPTIONS
|
| Medical devices; processing, labeling, or repacking. |
|
Subparts F-G--[RESERVED]
Subpart H--SPECIAL REQUIREMENTS FOR SPECIFIC DEVICES
|
| Labeling of articles intended for lay use in the repairing and/or refitting of dentures. |
|
|
| Use of impact-resistant lenses in eyeglasses and sunglasses. |
|
|
| Maximum acceptable level of ozone. |
|
|
| Chlorofluorocarbon propellants. |
|
|
| Hearing aid devices; professional and patient labeling. |
|
|
| Hearing aid devices; conditions for sale. |
|
|
| User labeling for menstrual tampons. |
|
|
| Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. |
|
|
| User labeling for latex condoms. |
|
|
| User labeling for devices that contain natural rubber. |
|
|
