The Food and Drug Administration (FDA) has announced the implementation of a new schedule of fees and charges under Administrative Order No. 2024-0016. For over two decades, the FDA’s fees were governed by Administrative Order No. 50 s. 2001. The restructuring of fees aims to align charges with the costs of regulating health products, establishments, and facilities to ensure consumer safety and public health.
The updated guidelines apply to all establishments, facilities, and health products under FDA jurisdiction, including public and private entities.
The updated guidelines apply to all establishments, facilities, and health products under FDA jurisdiction, including public and private entities.
Revised Fees and Charges for FDA-Regulated Health Products
The following table summarizes the comparison between the old fees under AO No. 50 s. 2001 and the new fees under AO No. 2024-0016 for licenses and certifications under the Center for Device Regulation, Radiation Health, and Research (CDRRHR):
Implementation Timeline
- This regulation will take effect 15 days after official publication in newspapers of general circulation.
- As of this writing, the AO has not yet been officially published.
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