Breakthrough Devices Program: Where’s the value?

To find out more about the FDA’s Breakthrough Devices Program and its potential value for your organization, please join Parexel’s MedTech Regulatory Strategy and Health Advances MedTech consulting leaders, along with medical device innovators who have been through the process, in this webinar-on-demand.

What you will learn:

  1. Motivations for, and expectations associated with being part of the Breakthrough Devices Program 
  2. Challenges and benefits of the program overall, beyond working more closely with the FDA
  3. Experiences throughout the process and implications for development and commercialization timelines
  4. Key lessons learned from those who’ve been through the process 
  5. Considerations for whether and how to pursue breakthrough status

Return to Insights Center

Related Insights

Webinar

Accelerating delivery of radiopharmaceutical trials

Oct 3, 2025

Blog

Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market

Nov 13, 2023

Report

New Medicines, Novel Insights: Advancing rare disease drug development

May 22, 2023

Report

New Medicines, Novel Insights: Accelerating development of cell and gene therapies

May 22, 2023

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Blog

Celebrating 40 Years of Rare Disease Progress: WODC Highlights

Jun 6, 2023

Blog

Population variability: important considerations in vaccine development

Jun 14, 2023

Whitepaper

How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU

Jun 28, 2023

Article

The technologies that are reshaping biotherapeutics manufacturing, an EU perspective

Jul 6, 2023

Blog

Ensuring future success in a new market by delivering a robust safety database solution

Aug 4, 2023

Whitepaper

Optimizing the Route to Regulatory Approval for a Novel Vaccine

Aug 18, 2023

Article

Australia: The Regulatory and Reimbursement Environment

Aug 28, 2023

Related Insights

Webinar

Accelerating delivery of radiopharmaceutical trials

Oct 3, 2025

Blog

Adoption of the ICH Q12 guideline: New Horizons for Efficient Product Supply Chain Management for a Key Global Market

Nov 13, 2023

Report

New Medicines, Novel Insights: Advancing rare disease drug development

May 22, 2023

Report

New Medicines, Novel Insights: Accelerating development of cell and gene therapies

May 22, 2023

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Blog

Celebrating 40 Years of Rare Disease Progress: WODC Highlights

Jun 6, 2023

Show more