Breakthrough Devices Program Updated Final Guidance

John E. Lincoln
Recording Webinar Available @All Days
Recorded Webinar


Join us for an informative webinar on the updated final guidance for the Breakthrough Devices Program. The FDA has issued critical updates to the program, addressing various aspects, including health equity, innovation, pain, addiction management, and transparency in device designation. Learn about these changes and gain valuable insights from industry experts.

Key Highlights:

  • What is the Breakthrough Devices Program?
  • Benefits of the program.
  • Clarifications on eligible devices, including those promoting health equity.
  • When and how to request a Breakthrough Device designation.
  • What to include in your request.
  • What to expect from the FDA if your device is designated as a Breakthrough Device?
  • She related expedited programs for specific devices.
  • FDA's disclosure process for Breakthrough Device status.
  • How many devices have received Breakthrough Device designation?
  • How many have received marketing authorization?
  • Available guidances related to the Breakthrough Devices Program.

Why Attend?

  • Introduction to the Breakthrough Devices Program
  • Eligibility and Designation
  • FDA Support and Disclosures
  • Breakthrough Device Statistics

Who Should Attend?

  • Medical device developers
  • Regulatory affairs professionals
  • Healthcare innovators
  • Industry stakeholders
  • Anyone interested in the latest developments in medical device regulation

Training Options

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