Breakthrough Devices Program Updated Final Guidance
From: Nov 14, 2023 - To: Dec 31, 2023
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, and 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?
Related expedited programs for certain 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 Should You 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
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