Regulatory Playbook for Innovative Medical Devices

Event Time

Originally Aired - Wednesday, November 3 10:00 AM - 10:45 AM

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Event Location

Location: 102BE

Event Information

Title: Regulatory Playbook for Innovative Medical Devices

Event Type: Technical Session

Badge Type: 2-Day Pass,1-Day Pass


Predictability is paramount when dealing with regulators. In this session, you’ll hear from a former FDA-reviewer about actionable ways technology pioneers can work with regulators to clarify the roadmap to US approval. FDA offers several programs that are intended to provide innovators with pathways for early shared problem solving. These engagements have a positive impact on upstream decision making, resulting in improved resource allocation and reduced costs of technology development. Learn tips for utilizing these programs to define the initial regulatory strategy and efficiently navigate the obligatory regulatory hurdles in commercializing a great idea.

Topics covered will include:

  • Tips for aligning strategy with Agency pre-submission meetings
  • Review of key features and ways to utilize FDA Breakthrough Device Designation
  • Introduction and advantages of FDA’s new (Mar 2021) Safer Technologies Program for Medical Devices
  • Use of FDA’s Early Feasibility Study program to iterate early device designs
  • Importance of aligning strategy across regulatory, clinical and reimbursement stakeholders for successful commercialization