Comment from Angela Perez

I support the FDA’s proposed rule to better classify blood irradiator devices because it just makes sense to treat these devices based on how they’re actually used and the level of risk involved. Separating devices used to prevent transfusion associated graft versus host disease (TA-GVHD) from those intended to reduce metastasis is an important move. They serve very different purposes, so having different regulatory standards helps make sure each one is reviewed appropriately. I especially agree with placing devices meant to reduce metastasis into Class III and requiring premarket approval. Since these are higher risk and deal with serious conditions like cancer, it’s only right that they go through a more thorough review process. Strong clinical evidence should be required so patients and healthcare providers can trust that these devices are both safe and effective. At the same time, the approach to Class II devices for preventing TA-GVHD also seems reasonable. Using special controls allows for safety measures to be in place without making the process overly complicated. As long as these controls are clear and practical, they can help maintain patient safety while still allowing access to important treatments. Overall, this proposal feels like a step in the right direction. It shows that the FDA is trying to be more precise and thoughtful about how medical devices are regulated. By matching the level of oversight to the level of risk, this rule can help protect patients while still supporting innovation in healthcare.