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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come

Submitted by kBLASTER Team on

by Chris Henza and Geoff Hutchins for Medical Device and Diagnostic Industry (MDDI)

Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. An excerpt from this commentary stated the following:

Given the release of the “The 510(k) Program” document, it is clear that FDA is standing firmly behind the 510(k) process and is...

Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

Submitted by kBLASTER Team on

Draft Guidance published by FDA on December 27, 2011. This guidance document is being distributed for comment purposes only.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...

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