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:
- Motivations for, and expectations associated with being part of the Breakthrough Devices Program
- Challenges and benefits of the program overall, beyond working more closely with the FDA
- Experiences throughout the process and implications for development and commercialization timelines
- Key lessons learned from those who’ve been through the process
- Considerations for whether and how to pursue breakthrough status
Related Insights
Blog
New FDA biosimilars guidance: CES waiver pathway aligns with global regulatory approaches
Nov 11, 2025
Webinar
EU-CTR: Preparing for trial transition
Nov 30, 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
Whitepaper
Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
Sep 19, 2023
Related Insights
Blog
New FDA biosimilars guidance: CES waiver pathway aligns with global regulatory approaches
Nov 11, 2025
Webinar
EU-CTR: Preparing for trial transition
Nov 30, 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
Whitepaper
Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
Sep 19, 2023