Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process 2012

A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.

Objectives:
-Know the differences between the Traditional, Special and Abbreviated submissions
-Understand Substantial Equivalence and how it is applied
-Who is required to submit the application to FDA
-Where to submit the 510(k) and what to expect with the review and approval process
-When it is and is not required if you are a device company
-Exemptions to the submission process and special considerations
-How to locate a "predicate" device and go through the content and format of the 510(k)
-Understand the De Novo process and the expectations for possibly marketing a low risk device
-Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention