Do you hear that sound? It's the clock ticking away the days with no recourse for many medical device startups. Things are coming to a head with certain milestones that require interaction with and/or clearance by FDA. The agency has made this process increasingly smooth, but as of late December, FDA has been suddenly hamstrung by the government shutdown. This means that near-term milestones involving 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.
Currently FDA has furloughed more than 40% of its employees. The remaining employees are focused on "mission critical" endeavors. Unfortunately, the list of "mission critical" endeavors does NOT include:
Accepting user fees
Accept 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 22nd, 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 waiting for the doors to re-open to continue your interactions with FDA.
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-sub's, 513(g)'s, 510(k)'s and Denovo submissions, we'd suggest using the extra time to review and refine your 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 "lapse period".
Authors: Gene Parunak & Adrienne Harris
Sources: Hogan Lovells, FDA, HHS