FDA Offers Fee Breaks to Struggling Small Device Makers
Published Date: 7/31/2025
Notice
Summary
Hey small medical device businesses! The FDA just updated the rules on how you can prove financial hardship to skip some registration fees. This new guidance explains what info you need to share and how the FDA will decide if you qualify—making it easier to save money and keep innovating.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Waiver for Registration Fee If Hardship
If you run a small medical device business, the FDA’s final guidance explains how the Agency will determine whether your firm is experiencing “financial hardship” that makes it eligible for a waiver of its registration fee. This guidance updates the prior guidance issued August 1, 2018 and says FDA will use the updated criteria to decide waiver eligibility.
Guidance Lists Information FDA Will Review
The guidance details what information the FDA intends to review and consider when deciding whether a small medical device business qualifies for a financial-hardship waiver. If you apply for the waiver, you will need to provide the information the guidance lists so FDA can make its determination.
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