03/05/2024
This week, the FDA published its long-awaited rules for LDTs
The final rule mandates that all IVDs, including those developed in laboratories such as genetic tests, comply with the same FDA requirements as other medical devices.
The FDA says it will phase out its policy of enforcement discretion for LDTs in five stages over the next four years.
It’s a red-letter day for the genetic testing industry. We all said we’ll believe it when we see it. Well, we can now see it. This week, the FDA published its long-awaited rules for LDTs. After decades of exercising “enforcement discretion” and waving flags about using enforcement, they have...