Show me where in the process for a device to obtain FDA...

Show me where in the process for a device to obtain FDA clearance that the FDA requires evidence of its safety and effectivness?

I can't find any such requirement on its website.

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

"Generally, the FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class II devices are generally subject to special controls, which may include specific testing or labeling requirements for that device."