In FDA Substantial equivalence means to demonstrate a new device to be marketed is safe and effective with a predicate device for the premarket submissions. Substantial equivalence doesn’t require the predicate device and the subjective device are identical rather it can be demonstrated through intended use, design, materials, performance, safety, effectiveness, labeling, biocompatibility, and other applicable characteristics. Substantial equivalence can be claimed to a pre-amendment or post amendment device that is legally marketed.
What is pre-amendments and post amendments device? And how effectively use a predicate device?