FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list on March 21, 2024.This program is intended to provide patients and health care providers with timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Since the launch of the program, FDA has granted 933 Breakthrough Device designations, and authorized 95 Breakthrough Devices for marketing.
Click HERE for the FDA guidance of Breakthrough Devices Program
What is the Breakthrough Devices Program?
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness to be authorized for marketing. The Breakthrough Devices Program reflects our commitment to device innovation and protecting the public health.
The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.
What are the benefits of the Breakthrough Devices Program?
The Breakthrough Devices Program offers manufacturers an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase. This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.
Is my device eligible?
Devices subject to premarket approval applications (PMAs), premarket notification [510(k)], or requests for De Novo classification request are eligible for Breakthrough Device designation if the device meets certain criteria. To identify the eligibility of your device, please email info@accelgroups.com.
What can I expect from the FDA if Breakthrough Device designation is granted?
If your device is granted the Breakthrough Device designation, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options including:
- sprint discussions,
- request for discussion on a data development plan, and
- request for clinical protocol agreement.
You will also receive prioritized review on future regulatory submissions for the device, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.
How many devices have received Breakthrough Device designation?
As of December 31, 2023, CDRH and CBER have granted 933 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway (EAP) program. Of the 933 devices granted Breakthrough Device designation, CDRH has granted 921 and CBER has granted 12.
Among them, 95 devices have obtained market authorization.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
