The FDA is trying to facilitate quicker access for critically ill patients to novel medical devices through a new program for breakthrough devices.
In December 2018, it published a guidance document on the program.
In this article, we will explain how the Breakthrough Devices Program works and what requirements manufacturers must meet in order to be able to participate in it.
The FDA's aim is to open up a pathway for manufacturers to get their medical devices on the market faster. However, the program is only aimed at novel devices that help patients who are suffering a life-threatening disease or who are suffering an irreversibly debilitating disease or condition.
The Breakthrough Devices Program is not a new form of approval. Therefore, it is not an alternative to a Premarket Notification according to 510(k), a Premarket Approval, or a “De Novo Request”. Rather, the FDA wants this program to enable these existing approval procedures to be made quicker.
The program is open to medical devices and combination products. It replaces the following programs:
The FDA offers several improvements to the manufacturers included in this program:
Collaboration is therefore faster and more interactive - more like an agile approach.
For a manufacturer to be able to obtain approval for their devices through the Breakthrough Devices Program, it must meet several requirements.
The device is in the best interest of patients. This would be the case if the alternatives have major side effects or if the new device significantly improves the diagnostic options and their use.
There are two steps in the program. In the first step, the manufacturer must submit an application in which it explains why it means the above requirements. The FDA will make a decision on the application within a maximum of 60 calendar days, and will request any additional information it requires within 30 days.
In the second phase, the FDA and the manufacturer work together in sprints. During this phase, the FDA will not just be more available to the manufacturer, it will also give higher priority to the "project" than it would receive in other approval processes.
The FDA has once again shown us that it is genuinely able to weigh up benefits and risks. It has recognized that patients can be harmed just as much by refusals to grant approvals or delays to approvals for medical devices as they are by medical devices that are not sufficiently safe or effective.
It would be great if there were such a program in Europe as well. Unfortunately, with the MDR we're going in completely the opposite direction.