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
Past Events
How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2013 - 12-13 Dec 2013, DoubleTree by Hilton Hotel San Francisco Airport, Burlingame, California, United States (40578)
How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2013 - 07-08 Nov 2013, DoubleTree by Hilton Hotel Philadelphia Center City, Pennsylvania, United States (11586)
How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process 2026
Important
Please, check "How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process" official website for possible changes, before making any traveling arrangements
