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FDA Halts New Device Submissions Amid User-Fee Shutdown

10/3/2025

38 4 Full Breakdown

Summary

Story summary

U.S. Food and Drug Administration (FDA) halts new medical device submissions during the Oct 1, 2025 shutdown due to user-fee gaps.
About 86% of FDA staff will continue critical public health work.
Existing paid-fee applications will be processed; new submissions are paused.
The shutdown reduces reviews of unapproved drugs and inspections; the September 2022 reauthorization allowed higher fees.

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Story summary

U.S. Food and Drug Administration (FDA) halts new medical device submissions during the Oct 1, 2025 shutdown due to user-fee gaps.
About 86% of FDA staff will continue critical public health work.
Existing paid-fee applications will be processed; new submissions are paused.
The shutdown reduces reviews of unapproved drugs and inspections; the September 2022 reauthorization allowed higher fees.