Breakthrough Devices Program: What Focused Ultrasound Companies Need to Know1

In 2018, the US Food and Drug Administration (FDA) established the Breakthrough Devices Program to allow fast-tracking of certain novel devices. The program offers device manufacturers an opportunity to work directly with the FDA through the premarket review stage of the approval process. The overall goal is to expedite patient access to devices that provide more effective treatment or diagnosis – through a more rapid assessment and review process – while preserving the FDA’s standards of approval. 

On its website, the FDA describes the program, how to apply, and the benefits of receiving Breakthrough Device Designation (BDD). The process for submission is straightforward, and the response time for a request is relatively short (within 60 days). Also notable, the required clinical data bar is low, and the benefits to receiving BDD are many.  

How many devices have Breakthrough Device Designation? 
As of September 30, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) and the FDA Center for Biologics Evaluation and Research (CBER) have granted 1,041 BDDs, including devices that were originally included in the FDA’s Expedited Access Pathway Program. Of the 1,041 devices granted BDD, CDRH has granted 1,029 of them, and CBER has granted 12 of them. There are eight companies that have received BDD for focused ultrasound applications, which is a large number given the relative newness of the field. A BDD request can be submitted any time before submitting any type of FDA marketing submission (PMA, premarket notification [510(k)], or De Novo classification request).  

How do you apply? 
BDD is requested by submitting a “Designation Request for Breakthrough Device” Q-Submission through the FDA electronic portal (CCP – Sign In). A submission can be made through either the electronic Submission Template And Resource (eSTAR) or eCOPY, as described below.  

eSTAR is an interactive PDF document that guides applicants through the process of preparing a comprehensive medical device submission and automatically tracks the status of the document preparation. This is especially helpful when preparing a detailed submission, such as a request for a Q-presubmission meeting or a regulatory document submission (510(k), PMA, etc). There are different eSTAR forms depending on the type of submission, available here. 

eCOPY is a means for electronic submission of other interactive material, such as BDD submission, and follow-up questions to an eSTAR submission, etc. eCOPY requires any communication be converted to a zipped pdf format before submitting—the individual documents are placed in a folder on a computer which can then be “zipped” within the file viewer. eCOPY is the recommended method for BDD submission and the easier one to use. 

The FDA provides automated status updates on materials submitted through eSTAR and eCOPY. 

Why Breakthrough Device Designation? 
BDD is not an alternative path to regulatory authorization, nor does it alter the likelihood of a device receiving regulatory authorization. It does, however, offer many benefits to companies, including: 

1. streamlining the regulatory process
2. allocating more FDA resources to the company
3. facilitating faster communications between companies and the FDA
4. creating a “binding” agreement on regulatory clinical trials
5. prioritizing the company when it comes to the allocation of increasingly limited FDA resources
6. carrying a certain amount of cachet with investors and the public  

With eight focused ultrasound companies earning BDD to date, the program is shaping up to play a major role in helping to advance the commercialization of the technology. BDD was designed to help new technologies or innovations move more quickly through the regulatory process to get potentially life benefitting treatments to patients more rapidly. Given the potential focused ultrasound has to aid patients with currently untreatable or poorly treatable conditions – and given the propensity the FDA has shown in granting focused ultrasound technologies BDD across varied uses – companies in this space are encouraged to consider this path as they explore regulatory options for either new technologies or new uses for existing devices. 

More Resources 
For a first-hand account of a focused ultrasound company navigating the Breakthrough Devices Program, read “An Inside Look at Obtaining Breakthrough Device Designation.” 

Visit the FDA Breakthrough Devices Program Website