Substantial Equivalence
Substantial Equivalence is the demonstration that a new device, compared to a predicate device for t...
Abbreviated 510k & Guidance
The medical devices for which the FDA 510k or premarket notification is required from the US FDA bef...
Traditional 510k
The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k [&hellip...