CDRH’s Office of Device Evaluation (ODE) received 9415 major submissions in FY 2006, up 8.3% from 8690 in the previous fiscal year. The ODE 2006–2007 annual report says the increase is primarily due to a jump in the number of premarket approval (PMA) supplements received. In FY 2007, the number received went down to 9276. The average total elapsed time for original PMAs and panel-track PMA supplements has decreased overall from FY 2003 to FY 2006. The report says an increase in elapsed time in FY 2005 was likely due to a staffing shortage from that year because there was uncertainty over the continuation of the medical device user fee program. The average ODE review time from receipt to final decision for 180-day PMA supplements has continued to improve, the report says. For the FY 2007 receipt cohort, the average ODE review time was 95 days, down from 109 days in FY 2006 and 111 days in FY 2005. The report also sees a “significant improvement” in the average total elapsed time for 180-day PMA supplements since FY 2005. For the FY 2007 receipt cohort the total time was 126 days, down from 169 days in the FY 2006 receipt cohort and from 238 days in FY 2005. -- James G. Dickinson