Replies to post #24130 on Grapefruit USA Inc (GPFT)

[BennyJ]

Not More Information or AI(Additional information)
An FDA decision means either SE or NSE.(within 150 days, I expect before Sept 1st or 2nd week)
Read page number 6 of the below link provided.
II. DEFINITIONS AND EXPLANATIONS OF TERMS
A. FDA DECISION
PMA decisions are approval, approvable, approvable pending GMP inspection,not approvable, withdrawal, and denial. 510(k) decisions are substantially equivalent (SE) or not substantially equivalent (NSE).Not Approvable decisions will generally not be issued on the first review cycle.The rare cases where a not approvable decision might be issued on the first review...continued

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA

IMGG 510k is in interactive process.

I. REVIEW PERFORMANCE GOALS--FISCAL YEAR 2008 THROUGH 2012 AS
APPLIED TO RECEIPT COHORTS

All references to "days" mean "FDA days."

F. 510(K) SUBMISSIONS
FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.

Read Section H. INTERACTIVE REVIEW in the document, link has provided above, Above information also has been taken from the same document.

You can see the 1st quarter for 2010 and last quarter for 2009 in the below link. click April 20 and January links. In the next page click CDRH report. 100% within 150 days in both the last 2 quarters.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109210.htm