Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

Draft Guidance published by FDA on December 27, 2011. This guidance document is being distributed for comment purposes only. This guidance introduced the concept of primary predicate usage and excerpts from guidance document related to primary predicates are shown below:

...Section 513(i) of the FD&C Act states that for a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the (primary) predicate...