While FDA has generally been streamlining its pre-market review processes, accelerating the number of new devices that can reach the market, a significant headwind is in place for 2019: the ongoing partial shutdown of the US federal government.

During the shutdown, which will become the longest in US history (22 days) on Jan. 12, FDA cannot accept new PMAs, 510(k)s, de novos, or any submission that requires a user-fee payment. (Also see "As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?" - Medtech Insight, 2 January, 2019.) While the agency can continue to review applications submitted prior to the shutdown using carryover funds, limited resources are causing the agency to prioritize its efforts. (Also see "Gottlieb Takes To Twitter To Raise FDA Morale Amid Shutdown" - Medtech Insight, 4 January, 2019.) The last significant government shutdown, in 2013, lasted 16 days. That year, there were 49 novel device approvals, down from 61 the year prior.

The total PMA submission volume in FY 2018, which ended last September, was at an average level. And de novo request volumes declined in FY 2018 following a prior-year spike, so it is likely, with the impact of the shutdown, that the overall numbers of new devices that get through FDA in 2019 will drop.

2018 US Device Approvals: The Year Of De Novos And Digital Health

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