2025-12306Notice

FDA Wants Feedback on Sterilizing Device Shipping Forms – Yawn?

Published Date: 7/2/2025

Notice

Summary

The FDA wants your thoughts on a new form that helps track medical devices shipped for sterilization or extra work. This affects companies sending devices to be cleaned or repackaged, and the agency is asking for comments within 60 days. No big costs or changes yet—just making sure the paperwork is clear and easy to handle!

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

New Shipment Form for Sterilization

The FDA is asking for public comment on a proposed form to track nonsterile medical devices that are shipped to other establishments for sterilization, processing, labeling, or repacking. The agency is accepting comments for 60 days under the Paperwork Reduction Act of 1995. This change affects companies that send devices to be cleaned or repackaged.

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Key Dates

Published Date
7/2/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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