Medical Device Usability Studies * Medical Device Clinical Studies and Performance Testing * Regulatory Insight
Regulatory Compliance and Market Clearance for Medical Device & IVD Companies

Regulatory Insight * Specializing in FDA Registration & FDA Compliance. FDA and Medical Device Consulting.

Comprehensive worlwide regulatory consulting services.

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.

FDA Registration Consultants * FDA Compliance Consultants * 510(k) Submissions

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