How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2013

Topics

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