Government Shutdown: FDA not accepting 510(k) submissions and proposal to allow submissions likely to fail

During the government shutdown FDA has not been accepting new device submissions, including 510(k)s, as it cannot accept associated user fees - you can read their notice on user fees and staffing levels during the shutdown here. Additionally, as of January 18th, 54% of FDA staff was furloughed or partially furloughed.

While the shutdown will, at some point, end. For now, not only cannot manufacturers not make submissions to obtain FDA clearance on new devices thereby delaying the time to market, but FDA is also accumulating a backlog of ~300 devices a month that will delay clearance time once the shutdown ends. This is not good for industry or patients. But the best thing you can do is continue to work on your submissions. We are ready to support that and encourage you to look at our software platform for submissions that allows submissions to be done faster, done smarter. 100% of the 510(k) submissions built in our platform have got though the RTA review on the first pass - overall only 65% of 510(k) submissions achieve this mark of quality.

AdvaMed, a medical device industry lobbying group, has supported draft legislation to allow FDA to accept and process new device applications during the shutdown. However, it appears that this will fail as it is not supported by house democrats.