NEWS & BLOG

February 20, 2016

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...

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