FDA Moves to Tighten Oversight of Laboratory-Developed Tests to Make Them Safer and More Accurate

On Friday, The US Food and Drug Administration said that because of the growing use of these lab-developed tests and their importance in medical decision-making — some 70% of medical decisions depend on lab tests, according to data from the US Centers for Disease Control and Prevention — it proposed a rule aimed at increasing its oversight.

The proposed rule would treat laboratory-developed tests as medical devices and end the agency’s hands-off stance on them.

Source: https://edition.cnn.com/2023/09/29/health/fda-lab-tests-oversight/index.html