Replies to post #28731 on Medizone Intl. (fka MZEIQ)

[Eli's Gone]

I guess I am missing where the big bottleneck is with this FDA thing...

the Bossman said we would be classified as a Class 1 device exempt from marketing application requirements---a simple establishment registration (which I believe is on file- HERE), a device listing, and GMP adherence are all that is required--what's the big deal I ask?...

Most Class I devices and a few Class II devices are exempt from the requirement for submission of a marketing application. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.

http://www.601help.com/Regulatory/fda.html

[GreenOwner]

Fast Track program has been around for 2 years now.

http://ipspotlight.com/2011/04/04/uspto-implements-fast-track-patent-review-program/