FDA Registration Fees and Price List for 2026-2027
Our prices for FDA registration, U.S. Agent, listings, label review and import support across food, drugs, medical devices and cosmetics, in U.S. dollars. These are the fees you pay us. FDA's own government fees, which only some programs charge, are listed separately at the end.
Not sure which services you need? Tell us your product and country. We confirm the services and the total before any work begins.
Get a QuoteFood and Dietary Supplement Pricing
| Service | Our price | Notes |
|---|---|---|
| Foreign food facility registration | $858 per year | U.S. Agent included |
| Domestic food facility registration | $858 per year | Filing, updates and renewal |
| Food U.S. Agent (standalone) | $858 per year | For foreign food facilities |
| DUNS request assistance | $399 one time | Facility DUNS for registration |
| Food label and ingredient review | $250 per label | Includes a check of corrected artwork |
| HACCP plan development | $1,500 first product | $800 each additional product |
| Prior Notice filing | $35 per filing | Imported food shipments |
| FCE / SID submission | From $1,250 | Starting fee for the first SKU |
| FSVP and FSVP agent services | Custom quote | Based on products, suppliers and importer setup |
| Food safety plan / preventive controls | Custom quote | Facility and product specific |
| FDA detention and import alert support | Custom quote | Case-specific review and response |
| Amazon and marketplace FSVP support | Custom quote | Based on importer and product scope |
Details: Food services.
Drug Registration and Listing Pricing
| Service | Our price | Notes |
|---|---|---|
| Drug establishment registration | $849 per year | Professional registration service |
| Drug U.S. Agent | $849 per year | For foreign drug establishments |
| Labeler Code request | $349 one time | Required before NDC listing |
| NDC / drug product listing | $199 per code | An NDC is not FDA approval |
| Drug labeling and ingredient review | $250 per review | OTC and drug labels |
| Drug DUNS request assistance | $399 one time | Establishment DUNS |
| Drug listing verification document | Custom quote | Private verification, not FDA-issued |
| Drug Master File (DMF) services | Custom quote | Depends on DMF type and scope |
| Drug import alert removal | Custom quote | Case-specific |
Details: Drug services.
Medical Device Pricing
| Service | Our price | Notes |
|---|---|---|
| Medical device establishment registration | $849 per year | FDA's own annual fee is paid separately to FDA |
| Annual establishment renewal service | $849 per year | FDA's annual fee paid separately |
| Medical device U.S. Agent | $849 per year | For foreign device establishments |
| Medical device listing | $249 per device | Listing is not clearance or approval |
| Medical device label and product review | $250 per product | Labels and claims |
| Medical device DUNS assistance | $399 one time | Establishment DUNS |
| Laser accession report and submission | $3,500 per report | Standard laser product report |
| Registration and listing verification | Custom quote | Private verification, not FDA-issued |
| QMSR / cGMP support | Custom quote | Depends on quality-system needs |
| Import alert and device detention resolution | Custom quote | Case-specific |
Details: Medical device services.
Cosmetics and MoCRA Pricing
| Service | Our price | Notes |
|---|---|---|
| MoCRA facility registration + U.S. Agent | $849 per year | Facility registration renews every 2 years |
| MoCRA registration and listing maintenance | $849 per year | Ongoing updates |
| MoCRA cosmetic product listing | $200 per product | Listings updated annually |
| Cosmetic labeling and ingredient review | $250 per review | Labels and claims |
| Cosmetics DUNS request assistance | $399 one time | DUNS is optional on Form FDA 5066 |
| California Safe Cosmetics reporting | Custom quote | Scope reviewed before quoting |
| MoCRA listing verification | Custom quote | Private verification, not FDA-issued |
Details: Cosmetics services.
FDA Government Fees, Paid Directly to FDA
These are not part of our prices. FDA charges them directly, and only some programs have them. Food and cosmetic facility registration have no FDA fee.
| FDA fee (FY 2027) | Paid to FDA | Small business rate |
|---|---|---|
| Food facility registration | $0 | $0 |
| Cosmetic facility registration (MoCRA) | $0 | $0 |
| Medical device establishment registration (annual) | $13,785 | No reduced rate |
| 510(k) premarket notification | $28,653 | $7,163 |
| De Novo classification request | $191,020 | $47,755 |
| PMA, PDP, PMR, BLA | $636,732 | $159,183 |
| 513(g) request for information | $8,596 | $4,298 |
| Prescription drug application with clinical data | $4,600,753 | Waivers in limited cases |
Fees apply October 1, 2026 through September 30, 2027. Sources: FDA MDUFA fees page, FY 2027 device fee notice and FDA PDUFA page. FY 2026 device establishment fee was $11,423.
When Each Registration Renews
| Program | Renewal | Paid to FDA |
|---|---|---|
| Food facility (21 CFR Part 1) | Every even-numbered year, October 1 to December 31 (FDA renewal reminder) | None |
| Drug establishment (21 CFR Part 207) | Every year, October 1 to December 31 | None for most establishments |
| Medical device establishment (21 CFR Part 807) | Every year, October 1 to December 31 | Annual establishment fee |
| Cosmetic facility (MoCRA) | Every 2 years from initial registration; listings updated yearly | None |
What These Prices Do and Do Not Mean
Registration is not approval
Registration, listings, NDCs and accession numbers do not mean FDA approved, cleared or certified a product.
Custom quotes
FSVP, food safety plans, import alerts and DMFs vary with products, suppliers and history. We scope the case before quoting.
No hidden FDA fees
If FDA charges a fee, it is listed separately from our professional fee.
Get Your Price Before You Start
Send your product category, company location and U.S. plans. We confirm which services you need and your total price before any work begins.
- Food, drug, device and cosmetic services.
- Label reviews $250 per label in every category.
- All prices in U.S. dollars.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Food · Drugs · Medical devices · Cosmetics.
Get a QuoteFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — FDA Registration Fees and Pricing
Are these FDA government fees or professional service fees?
Unless a row says otherwise, prices on this page are professional service fees paid to FDA Registration Assistance. FDA charges no fee for food facility registration (FDA food facility registration page), cosmetic facility registration or most drug establishment registration. Medical device establishments are different: FDA charges a separate annual establishment registration fee, $13,785 for FY 2027 (FDA MDUFA fees page).
How much does food facility registration cost in 2026-2027?
Our professional fee is $858 per year for foreign food facility registration, which includes U.S. Agent service, and $858 per year for domestic food facility registration. FDA charges $0 to register a food facility (FDA food facility registration page). See our food facility registration cost guide.
Does FDA charge a government fee for food facility registration?
No. FDA does not charge a fee to register, update or renew a food facility registration (FDA food facility registration page). Third-party registration and U.S. Agent providers charge professional service fees.
What is the FDA medical device establishment registration fee for FY 2026?
FDA's FY 2026 annual medical device establishment registration fee was $11,423, covering October 1, 2025 through September 30, 2026. It has been replaced by the FY 2027 fee. Our professional service fee is separate.
What is the FDA medical device establishment registration fee for FY 2027?
FDA's FY 2027 annual medical device establishment registration fee is $13,785 for October 1, 2026 through September 30, 2027 (FY 2027 device fee notice). There is no small business discount on this fee. Our professional service fee is separate.
How much is the Laser Accession Report & Submission service?
The professional fee is $3,500 for one standard Laser Product Report / Radiation Safety Product Report preparation and submission package. Additional testing, variance work, extensive redesign, or separate medical-device submissions are outside the standard scope unless included.
How much does drug establishment registration cost?
Our professional Drug Establishment Registration service is $849 per year. Other FDA user fees may apply to specific drug programs or applications, but those are separate from this professional service.
How much is a Drug U.S. Agent?
Our Drug U.S. Agent service is $849 per year for applicable foreign drug establishments.
How much does an NDC / drug product listing cost?
Our professional NDC / drug product listing service is $199 per code or product. Possession of an NDC does not mean FDA approved the drug.
How much does MoCRA cosmetic facility registration cost?
Our MoCRA facility registration and annual U.S. Agent service is $849 per year when U.S. Agent representation is required. Registration does not mean FDA approval.
How often does a cosmetic facility renew its MoCRA registration?
Covered cosmetic facilities renew their FDA registration every two years from the date of initial registration. This is not a universal October-to-December even-year window.
How often are cosmetic product listings updated?
The responsible person must provide updates to covered cosmetic product listings annually. Our professional product listing service is $200 per product.
Is DUNS required for MoCRA cosmetic facility registration?
No. FDA's current Form FDA 5066 requires the facility FEI and lists the facility DUNS Number as optional. Our $399 DUNS service is available for companies that need a DUNS for business or other regulatory workflows.
Does FDA registration mean my product is FDA approved?
No. Facility registration, product listing, device listing, an NDC, or a radiation-report accession number generally does not mean FDA approved, cleared, certified, or endorsed the product. Separate premarket requirements may apply depending on the category.
How often do food facilities renew FDA registration?
Covered food facilities renew every two years during the October 1 through December 31 period of each even-numbered year.
How often do drug establishments renew FDA registration?
Drug establishments renew their registration every year between October 1 and December 31, and drug listing changes are reported each June and December.
How often do medical device establishments renew FDA registration?
Medical device establishments that must register renew every year between October 1 and December 31 and pay the annual FDA establishment registration fee at the same time. The FDA fee is separate from our professional renewal service.
Why are some services listed as Custom Quote?
Custom-quote services vary by product count, supplier count, technical complexity, agency history, corrective-action needs, or submission scope. We review the case before setting a professional fee.
How do I confirm which services I need?
Send us your company location, product category, manufacturing location, intended U.S. activity, and import structure. We will map the regulatory pathway and confirm the applicable professional fees before work begins.
Are prices shown in U.S. dollars?
Yes. All prices on this page are shown in U.S. dollars unless a specific service states otherwise.
How much does FDA approval cost?
It depends on the product. Most foods, dietary supplements and cosmetics do not need FDA approval at all, so there is no approval fee, only registration and compliance work. Medical devices may need a 510(k) ($28,653, or $7,163 for small businesses, in FY 2027), De Novo ($191,020) or PMA ($636,732) (FDA MDUFA fees page). New prescription drug applications with clinical data carry a PDUFA fee of $4,600,753 for FY 2027 (FDA PDUFA page).
Is there a small business discount on FDA fees?
For medical devices, yes for most premarket submissions, such as a reduced 510(k) fee of $7,163, if FDA grants small business status (FDA small business program). The annual establishment registration fee has no small business rate, although FDA may waive it for certain small businesses showing financial hardship, excluding the initial registration.
How much does an FDA certificate cost?
FDA does not issue registration certificates for food, drug, device or cosmetic facilities, and FDA charges nothing for one. Certificates sold by private companies, including ours, are verification documents, not FDA approval. FDA does issue export certificates, such as Certificates to Foreign Government, which have their own FDA fees.
Do FDA fees change every year?
Yes. FDA user fees, such as device and drug fees, are reset for each federal fiscal year, which runs October 1 to September 30. FDA publishes the new rates in the Federal Register, usually in late July or early August. Food facility and cosmetic facility registration remain free.
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