Let me clear something up....55 more specific clinical trials per FDA to get app in by end of month. FDA approval in some manner from panel by end of year. From phone call @ 0808 hrs today....I don't lie...I Stand For our Freedom....
By the way...just picked up some camos yesterday that ROCK! My wife was wearing my sand pants....HOT!
FDA is supporting IMDS-CTLM passed some test of FDA that is why they gave FDA Export certification
here information aboout what is FDA CERTiFICATION
What are FDA Export Certificates?
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a "certificate" for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.
Why do foreign governments want FDA Export Certificates?
In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, for example current Good Manufacturing Practice (cGMP) regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.