For devices like SCS, FDA approval signifies what?

In the context of devices like Spinal Cord Stimulators (SCS), FDA approval signifies that the device meets established standards for safety and efficacy. This means that the device has undergone rigorous testing and evaluation to ensure that it is safe for use and performs effectively for its intended purpose. The FDA's approval process involves assessing clinical data, manufacturing processes, and labeling to ensure that the device not only works well but also does not pose undue risks to patients.

This approval is a critical factor for healthcare providers and patients alike, as it assures them that the device has been thoroughly vetted and is reliable for medical use. Therefore, the correct choice accurately reflects the importance of FDA approval in ensuring that devices are both safe for patients and effective in treating medical conditions.