Topics
- Understand Substantial Equivalence and how it is applied
- Know 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 not required to submit the 510(k)
- 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)
- Review and discuss 510(k) applications for group discussion and interactive participation
- Understand the potential impact of FDA’s proposed changes to the 510(k) process and why manufacturers need to pay attention
- Q&A and FAQ`s
Who should Attend
Involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers, including Quality Assurance and quality control, Professionals in R&D, Operations, Production, Compliance, Engineering, Regulatory Affairs and all Levels of Management.
