Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process 2015

This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). 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


Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link:http://bit.ly/1KjeMGm
[email protected]
www.compliance4all.com