FDA 1st quarter performance report for 2010 510K 90% within 90 days 100% within 150 days decision issued...
Yes that's right. But that was only for 2010 510K. The FDA's overall statistics (shown on the FDA's website in the link I provided in my previous post) indicates that 98% of all 510K submissions are decided within 150 days. I certainly hope that we will have approval as soon as possible, but I don't want anybody to create a promise and hype which may not entirely be true.