How the Government Shutdown is Affecting Medtech

A month into the U.S. government shutdown, we’re checking in on how medtech has been affected so far. Importantly, while the FDA is not authorized to accept new device submissions or the user fees that fund reviews during the shutdown, submissions that were funded prior to December 22 are still expected to receive decisions on time (e.g., within 90 days for a 510[k]). We also note, As Hogan Lovells reports here, that the processing of investigational device exemptions (IDEs) is continuing as usual during the shutdown.

Of course, medical device user fee funding from FY2018 will eventually be exhausted; it’s currently estimated that 2018 funds will last another two to three months (pharma is believed to be in a more vulnerable position, with around a month of remaining funding). We look forward to a resolution for the shutdown and continue to be optimistic that the impact of the shutdown will be minimal for our industry.