FDA Registration Fees (2025)

“FDA registration fee” is a keyword often searched by firms wishing to register with the U.S. FDA, generally for the first time. The total cost of FDA registration generally has two main components outlined below.

FDA Registration Service Fees: Fees charged by the registration agent or agency for their services.
FDA Annual User Fees: Government-mandated fees to be paid annually for certain types of registrations and can vary for each industry.

FDA Registration Service Fees

FDA registration service fees can vary by provider. Larger, experienced companies often charge higher fees due to overhead costs, while smaller firms may offer lower rates. When selecting an FDA agent, consider their expertise, reliability, and stability, as switching agents can be cumbersome and time-consuming.

FDA Listing Inc. is a New York Corporation with years of experience that offers flat-rate registration packages to meet your FDA registration and compliance needs. Our company’s FDA registration service fee details for 2025 are posted below; you may click on each service to access the complete information page.

Food and Supplement Registrations & Label Review Fees

FDA Food Facility Registration………………………..……………………..395 USD

FCE Registration & SID Filling………………….……………………………. 795 USD

Food & Supplement Label Review…………..……………………………495 USD

FDA Food Facility Registration..……………………..395 USD

FCE Registration & SID Filling..…………………….. 795 USD

Food & Supplement Label Review..…………………495 USD

Cosmetic Registration (MoCRA) & Label Review Fees

Cosmetic Facility Registration…………………………………………………495 USD

Cosmetic Product Listing…………..…………………………………….……395 USD

Cosmetic Batch Certification……………………………………………..….395 USD

Cosmetic Label Review……………………………………………………………595 USD

Cosmetic Facility Registration..……………………..495 USD

Cosmetic Product Listing..……………………..…….395 USD

Cosmetic Batch Certification..……………………….395 USD

Cosmetic Label Review..………………………………..595 USD

OTC Drug Registration & Label Review Fees

OTC Drug Establishment Registration………………………………..495 USD

OTC Drug Listing……………….…………………………………………………..495 USD

NDC Labeler Code………………………………………………………………….395 USD

Drug Master File (DMF)………………………………………………………2,450 USD

OTC Drug Label Review……………..………………………………………….695 USD

OTC Drug Listing..………………………………..495 USD

NDC Labeler Code..………………………….…..395 USD

Drug Master File (DMF)..……………………..2,450 USD

OTC Drug Label review..……….…….………..695 USD

Medical Device Registration & Label Review Fees

Device Establishment Registration……………………………………..545 USD

FDA GUDID & Unique Device Identifier UDI…………………………395 USD

Device Label Review………………………………………………………………995 USD

Device Establishment Registration..………………545 USD

FDA GUDID & Unique Device Identifier UDI..…195 USD

Device Label Review..…………………………………….995 USD

Additional FDA Service Fees

FDA Registration Certificate & US Agent………………………………245 USD

FDA Import Alert & Detention Assistance…….………………………995 USD

FDA Export Certificate…………………………………………………………….495 USD

FDA Registration Certificate & US Agent..……..245 USD

FDA Import Alert & Detention Assistance..……995 USD

FDA Export Certificate..…………………………………495 USD

FDA Annual User Fees

The FDA collects fees from companies that manufacture specific products, such as drugs and medical devices, as well as from certain other entities, including some accreditation and certification bodies. These fees, known as “FDA user fees,” are part of FDA regulatory oversight to ensure safety, quality, and compliance with federal laws. Currently, there are several FDA user fee programs and important ones are described below:

1- The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies that manufacture certain human drugs and biological products.

Fee Category	Fee Rates for FY 2024	Fee Rates for FY 2025
Application Type
Requiring clinical data	$4,048,695	$4,310,002
Not requiring clinical data	$2,024,348	$2,155,001
Program	$416,429	$403,889

2- The Medical Device User Fee Amendments (MDUFA) fees are intended to enhance the efficiency of the FDA’s regulatory processes, improve patient access to safe and effective medical devices in the U.S., and promote innovation. MDUFA Device Establishment Registration User Fees for FY 2025 is 9,280 USD

Some other medical device-related fees for FY 2025 are:

Application Type	Standard Fee	Small Business Fee†
510(k)‡	$21,760	$5,440
513(g)	$6,528	$3,264
PMA, PDP, PMR, BLA	$483,560	$120,890
De Novo Classification Request	$145,068	$36,267

† Small Business Fee: Small businesses certified through the Small Business Determination (SBD) program with gross receipts or sales of $100 million or less are eligible for a reduced fee on Premarket Notification (510(k)), De Novo request, Premarket Applications (Premarket Approval Application (PMA)), and 513(g) request for classification information, among other things. For assistance submitting a Small Business Determination (SBD) request, please contact us directly by email or phone.

3- The Over-The-Counter Monograph Drug User Fee Program (OMUFA), established in 2020, allows the FDA to collect user fees from manufacturers of over-the-counter (OTC) drugs that are produced under a monograph and not subject to New Drug Application (NDA) requirements. The OTC Monograph Drug User Fee program does not assess a facility fee for human OTC drug products not produced under a monograph, such as OTC homeopathic products or OTC Unapproved/Other categories

Important note: The OMUFA fees are assessed and posted based on the manufacturing processing activity from the previous fiscal year. Suppose a facility is manufacturing or processing over-the-counter monograph drug products from January 1, 2024, through December 31, 2024; it will be assessed the FY 2025 facility fee and will receive an invoice sometime around May 2025.

OMUFA FY 2024 Facility User Fee Rates

Monograph Drug Facility (MDF) Facility Fee

$ 34,166

Contract Manufacturing Organization (CMO) Facility Fee

$ 22,777

4- The Generic Drug User Fee Amendments (GDUFA) is designed to improve generic drugs’ availability and enhance the FDA’s ability to review them efficiently. Introduced in 2012, GDUFA allows the FDA to collect fees from generic drug manufacturers, which helps fund the FDA regulatory activities related to generic drugs.

GDUFA FY 2024 and FY 2025 User Fee Rates

User Fee Type	FY 2024	FY 2025
ANDA	$ 252,453	$ 321,920
DMF	$ 94,682	$ 95,084

5—The Animal Drug User Fee Act (ADUFA), enacted in 2003, allows the FDA to collect fees from pharmaceutical companies that produce new animal drugs. These fees support the FDA’s efforts to regulate and evaluate these drugs to ensure their safety and effectiveness for animals and the safety of food products derived from treated animals.

Furthermore, the Animal Generic Drug User Fee Act (AGDUFA) was enacted in 2008; through AGDUFA, the FDA collects user fees from companies seeking approval for new generic animal drugs. The primary goal of AGDUFA is to ensure that the FDA has the resources to review and approve generic versions of animal drugs efficiently while maintaining their safety and efficacy for animals.

ADUFA Fee Rates:

User Fee Type	FY 2024	FY 2023
Application Fees – Full	$683,673	$659,364
Application Fees – Supplemental	$341,837	$329,682
Establishment	$174,200	$167,149
Product	$ 12,459	$ 11,375
Sponsor	$153,305	$149,636