Because OTC devices are intended for the mass consumer market, additional studies are required to ensure its safety and effectiveness in the hands of consumer not having the benefits of physician supervision or treatment. Requirements for receiving marketing clearance include:
a. Label comprehension study
Adequate directions enable a layperson to use an OTC device safely for its intended purposes. For OTC labeling to be clear and truthful (and not false or misleading), it must contain directions, warnings, and information on the intended uses and side effects and be presented in such a manner “as to render the label likely to be understood by ordinary consumers, including individuals with low comprehension ability, as assessed under customary conditions of purchase and use” (21 CFR 330.10 (a)(4)(v)).
b. User manual development
The FDA requires device manufacturers to supplement their products with printed manuals. The applicable law (21 CFR §801 and §809) considers user manuals to be an extension of a device’s labeling that clarifies its proper and safe use. Validation testing is designed to show that lay people can easily understand the usage instructions, and would use the device in a manner that would provide safe and effective treatment.