An Introduction to Research Use Only (RUO)

In the complex world of medical device development, regulation, and distribution, finding the appropriate label to put on a device may not be simple. When is one label appropriate over another? Does a device need to go through additional testing, verification, or validation? And what are the consequences of using the wrong label? In this eBook, we’ll cover the differences between Research Use Only (RUO) and a medical device – although, it’s generally a very clear distinction.

Download this eBook to learn more about:

• What RUO is and how it differs from similar adjacent labels
• FDA guidance on RUO products
• Appropriate RUO label use and the consequences of mislabeling products