Adequate Directions for Use

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Adequate Directions for Use
U.S. Department of Health and Human Services FOOD
AND DRUG ADMINISTRATION

• -Regulations found in 21 CFR 801
• -Over-the-Counter (OTC) Devices
• -Prescription Devices

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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)

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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.

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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)

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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.