What does SCS stand for in the context of FDA approval?

In the context of FDA approval, SCS stands for Subcutaneous Cell System. This terminology relates to medical devices or therapies that involve the placement of certain types of cells or tissues just beneath the skin, often for therapeutic or monitoring purposes. The FDA evaluates these systems to ensure they are safe and effective for their intended use, which is critical for ensuring patient safety and achieving the desired health outcomes.

For instance, subcutaneous devices can include insulin pumps or devices used for drug delivery, and their approval requires comprehensive data on their performance and safety profile. Understanding this terminology helps in grasping the regulatory landscape of medical devices and the significance of FDA evaluations in the realm of innovations in healthcare technologies.