Medisun Precision Medicine Ltd. (fka MPME)

[Roland Rick Perry]

How long it takes the FDA to "approve" a 510(k) submission.

Emergo conducted a review of public data on medical devices cleared by the US Food and Drug Administration between January 1, 2010 and December 31, 2014.

The 15,000+ device clearances examined went through the FDA’s Premarket Notification program, more commonly known as the 510(k). This process applies to nearly all Class 2 devices, and a relatively small percentage of Class 1 and 3 devices.

For purposes of analysis we separated the devices into four basic categories:

Traditional 510(k) submissions reviewed by internal FDA staff (72% of all)

Traditional 510(k) submissions reviewed by Third Party Reviewers authorized by the FDA (6% of all)

Special 510(k) submissions (20% of all)

Abbreviated 510(k) submissions (5% of all)

FULL STUDY RESULTS:

http://biotechstockreview.ning.com/profiles/blogs/how-long-it-takes-the-fda-to-approve-a-510-k-submission-1