Regulatory

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. The 2020 conference program will be available early this summer. 

View the 2019 full conference program

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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?
• eSTAR?

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 and health care providers.

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. Focus was on IMDRF activities and a deep dive look at initiatives designed as building blocks for the development of a Medical Device Single Review Program (MDSRP) to ultimately enable a single regulatory pre-market review to satisfy multiple regulatory jurisdictions.

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 medtech companies new opportunities to effectively interact with patients, physicians, employees and other stakeholders. However, as a highly-regulated industry, medtech companies must consider new evolving media in the context of the regulatory environment and rules of the road amidst rapid change in today’s communications in advertising and promoting their products.

In this session, participants gained an overview of how FDA regulates medtech company communications in the age of social media. Attendees also learned about AdvaMed’s recently updated Direct-to-Consumer Advertising Industry Principles and how they can help companies establish processes in compliance with current regulations. Then, a leading communications consulting firm outlined social media best practices both for companies with an established on-line presence and those just starting to explore the social media landscape.

Finally, representatives from a large and a small medtech company provided case studies on how they have successfully utilized these new communications platforms. A Q&A session with all panel participants conclude the session.