Emerging technologies, new regulations and a variety of other factors all contribute to the ever-evolving medical technology regulatory landscape.
Below are just a few of the Regulatory sessions that were offered at The MedTech Conference in 2019. Call for Sessions opens November 2019. Stay tuned to our website for more details.
CDRH Town Hall
This session offered an exclusive peek into FDA’s Center for Devices and Radiological Health (CDRH). This was a rare opportunity to interact directly with Dr. Jeffrey Shuren and other senior office leaders from CDRH. After Dr. Shuren provided an update on CDRH priorities, panelists answered specific questions from the audience.
The New World of 510(k)
The 510(k) process has continuously evolved since 1976. FDA has introduced several changes including RTA, QUIK review and the Safety and Performance Pathway. What is on the horizon?
- Limiting certain devices as predicates?
- The new Third Party Review program?
- Redefining the data that must be submitted in a 510(k)?
- Pre-Cert options?
Senior FDA management discussed their proposal for the ongoing improvement of the 510(k) process and the industry reaction to the proposals.
It Takes a Village: How the Health Care Community is Working Together to Tackle Cybersecurity
Managing cybersecurity in the health care community is a shared responsibility, all participants must proactively do their part. This panel explored the various ways in which the health care space is jointly tackling these issues, including perspectives from FDA, medical device manufacturers
Global Regulatory Convergence – Emerging Trends and Future Opportunities
The complexity of the global medical device regulatory landscape continues to increase. This session discussed recent information shared at the 2019 September International Medical Devices Regulatory Forum (IMDRF) meeting and included panelist reflections on these timely updates.
Going Viral: Best Practices in Social Media
Twitter. Facebook. Instagram. Social media platforms have transformed how individuals and corporations are communicating and sharing information. These and other burgeoning social media tools can provide
In this session, participants gained an overview of how
Finally, representatives from a large and