|
Home
gpo.gov
govinfo.gov
e-CFR Navigation Aids
Browse
Simple Search
Advanced Search
— Boolean
— Proximity
Search History
Search Tips
Corrections
Latest Updates
User Info
FAQs
Agency List
Incorporation By Reference
Related Resources
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.
Download the Code of Federal Regulations in XML.
Download the Electronic Code of Federal Regulations in XML.
Monthly Title and Part user viewing data for the e-CFR is available for download in CSV format.
Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF
Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.
Purchase individual CFR titles from the U.S. Government Online Bookstore.
Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.
[A2]
|
|
Electronic Code of Federal Regulations
| e-CFR data is current as of December 12, 2019
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
Subpart A—GENERAL LABELING PROVISIONS
|
| Medical devices; name and place of business of manufacturer, packer or distributor. |
|
|
| Meaning of intended uses. |
|
|
| Medical devices; adequate directions for use. |
|
|
| Medical devices; misleading statements. |
|
|
| Medical devices; prominence of required label statements; use of symbols in labeling. |
|
|
| Medical devices; Spanish-language version of certain required statements. |
|
|
| Format of dates provided on a medical device label. |
|
Subpart B—LABELING REQUIREMENTS FOR UNIQUE DEVICE IDENTIFICATION
|
| Label to bear a unique device identifier. |
|
|
| General exceptions from the requirement for the label of a device to bear a unique device identifier. |
|
|
| Voluntary labeling of a device with a unique device identifier. |
|
|
| Form of a unique device identifier. |
|
|
| Devices that must be directly marked with a unique device identifier. |
|
|
| Labeling requirements for stand-alone software. |
|
|
| Request for an exception from or alternative to a unique device identifier requirement. |
|
|
| Discontinuation of legacy FDA identification numbers assigned to devices. |
|
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. |
|
|
|
