As you may already know, the U.S. Government remains shut down due to an ongoing disagreement over funding for government operations. As of November 5, 2025, this marks day 36 of the shutdown, officially making it the longest government shutdown in U.S. history.
What This Means for Our Industry
At this time, the FDA has suspended all Establishment Registration and medical device submission services. Since the start of the shutdown, the FDA User Fee Portal has disabled the ability to process registration and submission-related payments. As a result, new medical device submissions and establishment registrations are not currently being accepted.
Because we support many clients with FDA establishment registration and medical device listing services, we understand the significant impact this situation may have on ongoing and upcoming projects.
Our team is closely monitoring updates from the FDA and will continue to provide the latest information regarding the FY2026 Establishment Registration period as soon as it becomes available. Please stay tuned to our page for further updates once government operations resume.