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Adequate Directions for Use

US-unique

The "adequate directions for use" requirement is a core US labelling concept with no direct equivalent in other frameworks. It underpins the prescription/OTC device distinction.

The requirement​

Under 21 CFR § 801.5, labelling must bear adequate directions for use — directions under which a layperson can safely use the device for the purposes for which it is intended.

"Adequate directions for use" means directions that are:

  • Stated in ordinary terms
  • Include the quantity of each application
  • Include any frequency of application
  • Include the duration of application
  • Include any relevant precautions, warnings, and contraindications

Prescription device exemption​

Devices that are restricted to sale by or on the order of a licensed practitioner (prescription devices) are exempt from the adequate directions for use requirement under 21 CFR § 801.109 — because a layperson is not the intended end user.

Instead, prescription device labelling must include adequate information for practitioners, including:

  • Indications for use
  • Effects, routes, methods, and frequency of use
  • Relevant contraindications, side effects, and precautions

Exemption for OTC devices already in common use​

Some OTC devices (those sold directly to consumers without a prescription) are sold with labelling that achieves adequate directions for use through the combination of label and IFU.

Official resources​