Timely Considerations for Selecting 510(k) Cleared Saliva Collection Devices

Timely considerations for selecting 510k cleared saliva collection devices for genetic testing and molecular diagnostics
This 20-minute on-demand presentation sheds light on crucial aspects of bringing a genetic test to market. It covers:
• Advantages of FDA-Cleared Devices: Explore the benefits of utilizing US FDA-cleared Oragene•Dx and ORAcollect•Dx saliva collection devices in genetic tests and molecular diagnostics.
• Navigating Regulatory Considerations: Gain insights into the regulatory landscape for IVDs and LDTs and the strategic path for bringing genetic tests to market while complying with evolving regulations.
• Ease of Use and Customization: Understand the evidence supporting the ease of use of saliva collection devices with U.S. FDA general clearance. Learn how test kits can be customized to meet specific requirements, with streamlined offerings for test providers, and enabling a convenient experience for patients.