Grapefruit USA Inc (GPFT)

[BennyJ]

Here is the 2009 FDA performance review on 510k.

Tremendous improvments in Average Total elapsed time from 115 days to 98 days(from 2008 to 2009)

Average total elapsed days = ave # of days from receipt to final approval decision (FDA time + manufacturer time)

- 510(k) Review Performance
As shown in Figure 6, the average FDA review time from receipt to final decision increased in recent years but leveled off in FY 08. Average FDA review time for the FY 09 receipt cohort (which is still incomplete) stands at 63 days, compared to 65 days for FY 08 receipts. Average total elapsed time from receipt to final decision stands at 98 days for the FY 09 receipt cohort (still incomplete), compared to 115 days for FY 08 receipts (Figure 7).

Total Review Times
Beginning with the FY 2009 MDUFA Performance Report, FDA will provide summary review statistics on the total time required to render an FDA final decision, measured in elapsed days from receipt (or filing, for applications subject to filing) to FDA’s final decision. The summary review statistics will include industry time, and provide an indication of how well FDA and industry are doing in their mutual goal of seeing that reasonably safe and effective medical devices reach patients and healthcare professionals as rapidly as is consistent with an efficient and effective review process. FDA will update the data for each cohort in subsequent reports until each cohort is complete (meaning there is an FDA final decision, or an applicant withdrawal, for each application in the cohort).

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM223893.pdf