The Food and Drug Administration inconsistently met performance goals for pre-market approval submissions of medical devices although the agency has regularly met performance goals for the less-stringent 510(k) process, according to a government report (PDF)
In contrast, the Government Accountability Office found that review times and the times to final decision for PMA and 510(k) submissions have increased over recent years.
“Questions have been raised as to whether FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner,” the GAO wrote.
The 510(k) process is used to review devices deemed substantially equivalent to another device already on the market; the PMA process is the more stringent of the two review pathways and is used to review high-risk devices.
Nearly 90% of the device submissions received by the FDA from fiscal 2008 to 2010 were 510(k) submissions, according to the report.
Review times for the 510(k) submissions decreased from fiscal 2003 to fiscal 2010 although times to final decision increased during the same period. During the same seven-year period, review times and times to final decision for PMA submissions rose.
Review times are defined as the time the FDA spends reviewing submissions and do not include time spent by the agency waiting for manufacturers to submit additional information. Time to final decision is defined as the total time from the submission date to the date of the FDA's final decision.
“While FDA has met most of the goals for the time frames within which the agency was to review and take action on 510(k) and PMA device submissions, the time that elapses before a final decision has been increasing,” the GAO said. “This is particularly true for 510(k) submissions, which comprise the bulk of FDA device reviews.”
The report was released as Congress seeks to reauthorize the medical device user-fee program, which expires Sept. 30.
Earlier today, the Senate Committee on Health, Education, Labor, & Pensions held a hearing
about the reauthorization of the device and prescription drug user-fee programs
, as well as the introduction of user-fee programs for biosimilars and generic drugs.
The FDA agrees to performance goals as part of the user-fee program.