MDMA has expanded this popular seminar to TWO days, and will focus on unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as what changes may come as a result of FDA reform efforts. Presentations will be made by leading FDA attorneys, industry representatives and FDA officials.
This Seminar will Cover:
- Formatting and the Necessary Content for a 510(k)
- PMA Review Strategies and Communications
- Clinical Trial Considerations and Compliance Oversight
- How to Avoid Common Mistakes and Roadblocks
- Potential Impact, Proposed changes to the Premarket Review Process
The program will provide valuable insight from a variety of perspectives and give companies considering submitting a 510(k) or PMA in the future the tools they need to prepare successful submissions.