Research Use Only (RUO) products are non-invasive and non-diagnostic which only require “For Research Only” labeling under FDA guidelines. The FDA defines Laboratory Developed Tests (LDTs) as in vitro diagnostic products (IVDs) designed, manufactured, and used within a single laboratory. Although the FDA does not regulate RUO and LDT products today, many companies have future plans to expand indications turning their RUO or LDT products into regulated medical devices.

Jama Connect for Medical Devices provides an easy-to-use, out-of-the-box, flexible framework that enables development teams to begin with this framework and seamlessly transition to the regulatory-compliant medical device framework if necessary.

Read this datasheet to learn more about key benefits:

• Define RUO requirements as good business practice
• Prepare for future iterations
• Reduce wasted time and risk with automated tracking and collaboration