|
|
|
Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 801--LABELING
|
|||
 |
 | 801.1 | Medical devices; name and place of business of manufacturer, packer or distributor. |
|
|
| 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. |
|
|
| 801.60 | 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. |
|
|
| 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. |
|
|
| 801.150 | Medical devices; processing, labeling, or repacking. |
|
|
| 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. |
|
|
| 801.430 | 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. |
|
|
| 803.1 | Scope. |
|
|
| 803.3 | Definitions. |
|
|
| 803.9 | Public availability of reports. |
|
|
| 803.10 | General description of reports required from user facilities, importers, and manufacturers. |
|
|
| 803.11 | Obtaining the forms. |
|
|
| 803.12 | Where to submit reports. |
|
|
| 803.13 | English reporting requirement. |
|
|
| 803.14 | Electronic reporting. |
|
|
| 803.15 | Requests for additional information. |
|
|
| 803.16 | Disclaimers. |
|
|
| 803.17 | Written MDR procedures. |
|
|
| 803.18 | Files and distributor records. |
|
|
| 803.19 | Exemptions, variances, and alternative reporting requirements. |
|
|
| 803.20 | How to report. |
|
|
| 803.21 | Reporting codes. |
|
|
| 803.22 | When not to file. |
|
|
| 803.30 | Individual adverse event reports; user facilities. |
|
|
| 803.32 | Individual adverse event report data elements. |
|
|
| 803.33 | Annual reports. |
|
|
| 803.40 | Individual adverse event reporting requirements; importers. |
|
|
| 803.42 | Individual adverse event report data elements. |
|
|
| 803.50 | Individual adverse event reports; manufacturers. |
|
|
| 803.52 | Individual adverse event report data elements. |
|
|
| 803.53 | Five-day reports. |
|
|
| 803.55 | Baseline reports. |
|
|
| 803.56 | Supplemental reports. |
|
|
| 803.58 | Foreign manufacturers. |