The Food and Drug Administration has become faster at approving premarket approval applications submitted by makers of medical devices, according to a recently released annual report from the agency.
In fiscal 2006, the agency’s Office of Device Evaluation (ODE) took an average of 335 days to approve devices that ranged from X-ray machines to syringes compared with an average of 438 days the agency took to approve devices in fiscal 2005, the report stated.
The FDA said the average total elapsed time from filing to approval for original PMAs and panel track PMA supplements decreased overall from fiscal 2003 to fiscal 2006–with a slight increase in fiscal 2005, which the agency attributed to a staffing shortage that occurred in 2005 because of uncertainties regarding the continuation of the Medical Device User Fee Program. This trend for a decrease in total elapsed time was not accompanied by a consistent decrease in total FDA review time, the agency noted.
Because a final decision has not yet been issued for a significant number of PMA submissions received in fiscal 2007, the ODE review performance results for 2007 were not included in the report.
During fiscal 2006, the ODE received 9,415 major submissions, up from 8,690 in 2005. This increase was primarily the result of an increase in the total number of PMA supplements received. In fiscal 2007, the number received decreased to 9,276.
Of the 1,087 PMA supplements received in fiscal 2007, 234 were categorized as 180-day PMA supplements, up from 212 in fiscal 2006 and 169 in fiscal 2005.
The average review time from receipt to a final decision that closes a file (such as an approval, a withdrawal or a conversion) for 180-day PMA supplements has continued to trend downward. For fiscal 2007, the average review time was 95 days, down from 109 days in fiscal 2006.
According to Reuters, the FDA said the average review time from receipt of application to a final decision decreased after Congress revamped device regulations in 2002 to help streamline the agency’s device-review process and to set review time goals. The law also permitted the FDA to levy fees on device makers to help fund the review process.
As part of the effort to make the review process more efficient, the FDA set up third-party programs in which independent companies review device-maker applications before the agency makes its final decision. According to the FDA’s report, the Food and Drug Administration Amendments Act of 2007 includes a provision extending authority for third-party review of 510(k)s through the end of fiscal 2012; the existing statutory authority was scheduled to expire at the end of 2007.
The ODE made final decisions on 230 “third party” 510(k)s in fiscal 2007, a 13 percent decrease from the 264 final decisions it made the year before. However, the average total days from the time the ODE received a 510(k) with a third party’s review to the time it issued a final decision to the 510(k) holder was 43 days in fiscal 2007, slightly higher than the average of 39 days in fiscal 2006.
In fiscal 2007, the ODE completed 103 PMA actions, including 32 filing decisions, 30 major deficiency decisions and 41 approval/approvable/not approvable decisions. Of those 41 decisions, 27 were approval orders, seven were approvable and seven were not approvable. Of the 27 approvals, three were for expedited PMAs.?
The ODE completed 3,052 510(k) actions in fiscal 2007, including 2,640 substantially equivalent decisions, 95 not substantially equivalent decisions and 317 “other” decisions. In fiscal 2006, the ODE completed 3,080 510(k) actions, including 2,677 substantially equivalent decisions, 98 not substantially equivalent decisions and 285 “other” decisions, such as withdrawn or deleted.
–From VerusMed.com
