FDA's Device Detention and Ban Info Roundup
Published Date: 6/16/2025
Notice
Summary
The FDA wants to collect info about holding and banning certain medical devices to keep people safe. This affects companies making or selling these devices, who’ll need to share some details with the government. The FDA is asking for approval to gather this info soon, with no big costs expected for businesses.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Manufacturers Must Share Device Holding Info
If you make or sell certain medical devices that are held or banned, the FDA is asking for information from your company about those devices. The notice says businesses will need to share details with the government, and the FDA expects no big costs for businesses from this collection.
FDA Info Collection Aims to Protect Patients
The FDA will collect information about holding and banned medical devices to help keep people safe. You may benefit because the information is intended to support actions that protect patients from unsafe devices.
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Key Dates
Department and Agencies
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