Sampling Plan
The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable qua...
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 510k or premarket notification is required from the US FDA before ...
FDA 510(k) Summary or Statement
FDA 510(k) Summary or Statement is part of the 510(k) file of a medical device that requires the Pr...
Traditional 510k
The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k can be u...