Do you hear that sound? It’s the clock ticking away the days with no recourse for many medical device startups during the government shutdown.
Things are coming to a head with certain milestones that require interaction with or clearance by the FDA. The agency has made this process increasingly smooth, but as of late December, the FDA has been suddenly hamstrung by the government shutdown. This means that near-term milestones involving the FDA are on-hold for many startups, and even when the government re-opens, it may take time for the process to get back in full swing.
The FDA Is Focusing on Mission Critical Endeavors
Currently, the FDA has furloughed more than 40% of its employees. The remaining employees are focused on “mission critical” endeavors. Unfortunately, those endeavors do not include the following:
Accepting user fees
Accepting any FY2019 regulatory submissions that require a user fee payment
The good news is that if you got your 510(k), 513(g), or similar submission and payment in (and processed) prior to December 22, 2018, you may have some traction in these intervening weeks. You may also be in luck if you are working on an IDE (for clinical trials). If not, you’re most likely be waiting for the doors to re-open to continue your interactions with FDA.
What to Do During the Government Shutdown
Startups usually measure their available runway in months, not years, so a shutdown of a month will be a large setback to many projects. Just remember to be nice to the review staff at FDA when they get back. It’s likely that many of those folks will have been without pay for the past month or so.
For pre-submissions, 513(g)s, 510(k)s, and Denovo submissions, we suggest using the extra time to review and refine the development timeline, design data, and test results that are going into your submission. Feel free to reach out if you’d like assistance in these or other development matters during this shutdown.