Adequate directions for use
Download
1 / 5

Adequate Directions for Use - PowerPoint PPT Presentation


  • 318 Views
  • Uploaded on

U.S. Department of Health and Human Services FOOD AND DRUG ADMINISTRATION. Adequate Directions for Use. - Regulations found in 21 CFR 801 -Over-the-Counter (OTC) Devices -Prescription Devices. OTC Device. U.S. Department of Health and Human Services FOOD AND DRUG ADMINISTRATION.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Adequate Directions for Use' - Anita


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Adequate directions for use l.jpg

U.S. Department of Health and Human Services

FOOD AND DRUG ADMINISTRATION

Adequate Directions for Use

-Regulations found in 21 CFR 801

-Over-the-Counter (OTC) Devices

-Prescription Devices


Otc device l.jpg
OTC Device

U.S. Department of Health and Human Services

FOOD AND DRUG ADMINISTRATION

  • Available for purchase directly by any lay person/consumer

  • Require adequate directions for use for a lay person (21 CFR 801 Subpart C)


Prescription device l.jpg
Prescription Device

U.S. Department of Health and Human Services

FOOD AND DRUG ADMINISTRATION

  • A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such a device, and hence for which “adequate directions for use” cannot be prepared.


Prescription device cont l.jpg
Prescription Device (cont.)

U.S. Department of Health and Human Services

FOOD AND DRUG ADMINISTRATION

  • Prescription devices are exempt from the requirements of adequate directions for use for a lay person

  • Includes devices for use in a home, as prescribed by licensed practitioner (Rx Home Use)


Prescription use cont l.jpg
Prescription Use (cont.)

U.S. Department of Health and Human Services

FOOD AND DRUG ADMINISTRATION

  • Label the device (21 CFR 801.109)--“Caution: Federal law restricts the device to sale by or on the order of a _____”, the blank to be filled with the word “physician’, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device: and

  • The method of its application or use.


ad