Yesterday the FDA announced its “intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory.”
Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said, “With today’s notification of the agency’s intent to issue the lab-developed test draft guidance, the FDA is seeking a better balanced approach for all diagnostics. The agency’s oversight would be based on a test’s level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs.”
You can read the entire press release on the FDA website.
What do you think? How would this affect operations in your laboratory?