Program Support for Successful Inclusion in the FDA’s Breakthrough Devices Program

LBG’s expertise and support enabled a client to draft and submit a successful request for Breakthrough Devices designation.


A biomedical start-up company developed a novel approach for diagnosing Alzheimer’s disease, the most common neurodegenerative disease in the United States. This novel platform has shown the ability to detect diseases long before symptoms occur, thus allowing for early disease intervention. Based on advice from LBG, the client was seeking entry into the FDA’s Breakthrough Devices Program.

The Breakthrough Devices Program is a special program established by the FDA to help facilitate new and innovative solutions to help manage serious diseases for which there is a lack of either effective diagnostics or therapeutics. Inclusion into the program can help expedite feedback and interaction with the FDA and give the company priority review of regulatory submissions. This can greatly decrease product development timelines and indicate to investors the value of a product. (

For inclusion into the program, the client must present a compelling case for the validity of the technology, the uniqueness of the approach, and a clear regulatory pathway. In addition, they must also address how the technology will improve patient care. Since the client had little experience with either commercial diagnostic development or FDA interactions, they asked LBG to lead the development of the application.


Our team was selected based on our relevant experience. We took the lead role in planning and executing the strategy, which involved the development of key components of the application, including a proposed intended use (IU) statement, an analysis of risk, a compelling argument on how the technology meets specific Breakthrough Devices Program criteria, and a concise and clear presentation of the data supporting the submission. There is a significant amount of nuances involved in articulating an IU that is sufficiently broad to cover the client’s business needs but does not pose undue risk. In addition, the substantiating data must be presented to support the IU proposed and meet the Breakthrough Devices criteria.

Breakthrough Devices Program Criteria

We not only crafted the application, but we also took the lead on the correspondences with the FDA, which included responding to questions that had a short turnaround time.

Results and Impact:

As a result of our expertise and support, the company’s diagnostic was accepted into the FDA’s Breakthrough Devices Program within 60 days. This successful submission provides the company with a clear regulatory roadmap for their product development and significantly increases the likelihood of a successful submission. In addition, acceptance into the Breakthrough Devices Program represents a major milestone for this start-up company. Inclusion into the program was a key component of the company’s pitch to investors, which resulted in significant series A funding.