The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

Are you a Breakthrough product?

April 11, 2022

According to the FDA guidance, a breakthrough device is defined as:

“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 goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.”

The hardware and software device companies often assume that the device they are building is going to take a traditional pathway of prototype, test, regulation, and manufacturing (read our recommendation on revising this strategy). However, early engagement with the FDA or other regulatory bodies is not only beneficial for your product timeline, but may also prove financially and reputationally advantageous. Companies should request a presub meeting with the FDA early on to ensure that their assumptions on their path and tests are not challenged when it is submitted. Information not only helps the team, but also introduces your company to the FDA as a competent and intelligent group to work with. An addition to this recommendation is the Breakthrough Device potential. Devices that not only mitigate risk, but also generate benefits may potentially be given Breakthrough Device designation. For example, devices that detect a disease, solve a problem that is not completely solved today can be designated in this category.

A good question to ask yourselves is, “does the current solution solve the problem completely? Does it generate new risks or side effects? Do I solve this problem in a more acceptable or complete way?”. If any of these is true for your product, chances are you should apply for Breakthrough status. The Breakthrough Device designation application is a fairly straightforward document outlining your device’s attributes and benefits. One caution is that the Breakthrough application shouldn’t come in the middle of your presub request. Typically you should apply to Breakthrough first to see if you get it, then use the status to interact with the FDA for questions you would ask in a presub. When you submit your application, the FDA will review and give you a response within 60 days. The upside for your team would be access to the FDA subject matter experts who can guide you through the regulatory process, give insights on what the tests, criteria, and conclusions should be to submit your device, and expedited review process for your product category. If you think that’s not enough, try sharing the news with your investors and see if they are offended that you are a Breakthrough device. You’re welcome.


Chat with an Expert

Stuck on a particular problem? Speak with an expert to get your questions answered.