Cost of FDA Registration

The cost of FDA registration varies with the type of products and FDA classification. There are two costs involved: FDA government fees and consultant or US FDA Agent fees. LMG publishes all fees transparently.

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FDA Registration Fees — By Product Type

The cost of FDA registration varies with the type of products and FDA classification. There are two costs involved in the FDA registration process: FDA government fees and consultant or US FDA Agent fees.

Food Facility Registration: There are no FDA government fees for food facility registration. However, all foreign facilities must have a US FDA Agent. LMG fees for US FDA Agent service are $349/year, including a free certificate of FDA registration.

Medical Device Registration: There is an FDA user fee for medical device establishment registration. FDA fees vary each year (e.g., $11,423 for 2026). LMG fees for US FDA Agent service for a medical device establishment are $449/year. Device listing fees are $50/device. Please visit the FDA Fees page for device clearance or approval fees.

Drug Establishment Registration: There is a fee for OTC Monograph drug manufacturing facility registration (OMUFA fee). There are no FDA fees for other types of drug establishment registration. LMG fees for drug establishment registration and US Agent service are $649/year. LMG fee for drug listing is $399/listing.

Cosmetic Facility Registration (MoCRA): There are no FDA fees for cosmetic facility registration. LMG fees for cosmetic facility FDA registration and US Agent service are $649/year.

If your drug requires NDA or ANDA approval, FDA review fees apply. Please visit our full Fees page for complete, up-to-date pricing. FDA does not issue a registration certificate, but as your US Agent, LMG will issue a registration certificate after completing registration.

Frequently Asked Questions

Common questions about FDA fees.

Is there an FDA fee for food facility registration?

No. There are no FDA government fees for food facility registration. However, all foreign facilities must have a US FDA Agent, which involves a consultant fee.

What is the FDA fee for medical device registration?

FDA fees for medical device establishment registration vary each year. For 2026, the fee is $11,423 per establishment. Please check our Fees page for the current year’s fee.

Is there an FDA fee for drug establishment registration?

There are no FDA fees for standard drug establishment registration. However, OTC Monograph Drug manufacturers are subject to the OMUFA annual facility fee.

What does LMG charge for FDA registration?

LMG fees are published on our Fees page. For US FDA Agent service: Food $349/year, Medical Device $449/year, Drug $649/year, Cosmetics $649/facility. All fees include a free registration certificate.

Does FDA charge for cosmetic registration?

No. There are no FDA government fees for cosmetic facility registration under MoCRA.