Is FDA Breakthrough Device Status Still Worth It? 2025 Real-World Pros, Cons, and Surprises
Key Takeaway While FDA’s Breakthrough Device Designation program has grown to nearly 1,200 designations as of 2025, significant concerns about its value proposition have emerged, particularly considering recent FDA staffing cuts. For many companies, especially those pursuing 510(k) clearance, the program may no longer deliver meaningful benefits and could potentially increase regulatory burden. Current State…