FDA 510k Clearance in 2 months? Yes, it’s possible.
We have recently completed a regulatory submission and approval in an extremely short amount of time. On average, it takes 5 months for the FDA to review and clear a medical device 510(k) application. Most people think they have a good chance of getting their 510(k) clearance within 90 days, but that’s not the reality. The reality is that only 28% of 510(k) submissions cleared in 2013 were done within 3 months. So, the 90