Often when applying for over-the-counter (OTC) versus prescription indications for use for a device, a usability study is required. A usability study is intended to determine whether a lay person (i.e., the end user of the device) can safely and effectively use the device following the instructions for use without the aid of a medical professional. The usability study may be part of a human clinical study or it may be its own study, when a clinical study is not required, but the company wishes to obtain OTC approval or clearance for a current prescription device. Usability studies are also often useful during the design and development phase of a product. Regulatory Insight has designed, executed and analyzed the outcome of numerous usability studies to successfully support regulatory submissions for over-the-counter indications for use. We would welcome the opportunity to assist your company in developing a usability study for your device as well.