2025-10387Notice

FDA Simplifies Fee Discounts for Small Device Innovators

Published Date: 6/9/2025

Notice

Summary

The FDA is asking for approval to collect info from small medical device businesses to see if they qualify for fee discounts. This helps small companies save money when they submit their devices for approval. If you run a small medical device business, keep an eye out for deadlines to apply and save some cash!

Analyzed Economic Effects

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

Small Medical Device Fee Discounts

If you run a small medical device business, the FDA will collect information to determine whether you qualify for user-fee discounts when you submit devices for approval. The collection is submitted to OMB for review under the Paperwork Reduction Act, and small businesses should watch for deadlines to apply to receive those discounts.

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Key Dates

Published Date
6/9/2025

Department and Agencies

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