Topics
- Substantial Equivalence and how it is applied
- 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
- Exemptions to the submission process and special considerations
- When it is and is not required if you are a device company
- Understand the De Novo process and the expectations for possibly marketing a low risk device
- How to locate a "predicate" device and go through the content and format of the 510(k)
- Understand the potential impact of FDA`s proposed changes to the 510(k) process and why manufacturers need to pay attention
Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process brings together attendees involved in premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers including Quality Assurance, R&D, Production, Quality Control, Engineering, Operations, Compliance and Regulatory Affairs.
