Fees for the right to sell licensed or authorized Class II, III or IV medical devices

Fee for the right to sell licensed or authorized Class II, III or IV medical devices as of April 1, 2026
Fee category Description Fee as of April 1, 2025 Fee as of April 1, 2026
Medical devices The annual fee for the right to sell either a licensed Class II, III or IV medical device or an authorized Class II, III or IV medical device that is not an urgent public health need (UPHN) medical device $452 $460

For relevant guidance documents and forms, please visit Fees for medical devices.

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2025-12-01