Adequate Directions for Use

1. 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

2. 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)

3. 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.

4. 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)

5. 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.