One of the results from the recent two-week government shutdown is a backlog of government submissions. Although during the shutdown, the FDA continued to review device submissions that were submitted prior to October 1st, the agency was prevented from accepting any new fiscal year 2014 user-fee funded device submissions, including PMAs and 510(k)s.
On October 17th the government re-opened and now the Center for Devices and Radiological Health (CDRH) has to figure out how to address a large influx of submissions that were stalled during the shutdown. Some in the industry are anxious to hear how the FDA plans to deal with the backlog, particularly how the backlog will impact its ability to meet user-fee performance goals.
In an October 14th interview with the Gray Sheet, Peper Long, CDRH’s associate director for external relations indicated “we are working on a plan for how best to handle the backlog of FY 2014 submissions that are subject to a user fee and will communicate that plan to the industry.”
However, many feel the agency does not have the resources to deal with the surge and would like to hear a plan outlined. Phip Phillips, president of Phillips Consulting Group an former deputy director of CDRH states based on his experience “the agency doesn’t deal well with an onslaught of new applications at once.”
Many feel the FDA is ill-equipped to handle the backlog and may feel the shutdown will have a negative impact on their ability to meet many of the goals they have set. There are many differing opinions on the long-term impact. One potential casualty could be start-up companies that are revenue starved and living off venture capital investment. They rely on the FDA approval and this could be a devastating set back. This would be an unfortunate side-effect, having small start-up companies fold due to financial losses while awaiting FDA review.
Beyond the impact of the shutdown, many in the industry remain concerned about the uncertainty of the government budget process. Like other industries, the medical device industry wants a permanent fix, so they have some certainty moving forward. Industry is concerned about the potential of another shutdown and having to deal with the FDA or any other government agency.
Was your business impacted by the government shutdown? Share your thoughts on how the FDA should deal with this backlog.
Photo Credit: cseeman