FDA U.S. Agent cost: what you pay and what to expect
Transparent pricing for FDA U.S. Agent services. Assurentry charges a flat $399/year for food, drugs, medical devices, and cosmetics — no hidden fees, no per-communication charges.
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What's included
- FDA designation filing
- Acceptance letter
- Communications forwarding
- Renewal reminders
- Inspection coordination
- Dedicated support
Quick answer: FDA U.S. Agent cost
Assurentry's FDA U.S. Agent service costs $399 per year. This flat rate covers food, drugs, medical devices, and cosmetics. There are no hidden fees, setup costs, or per-communication charges. Many competitors charge $500–$1,500+ annually and often add fees for forwarding FDA letters or renewal assistance.
What's Included in Your U.S. Agent Service
Full representation and compliance support for $399/year — no hidden fees, no per-communication charges.
FDA Designation Filing
We file your U.S. Agent designation with FDA on your behalf for food, drugs, medical devices, and cosmetics — ensuring full regulatory compliance.
FDA Acceptance Letter
Receive your official U.S. Agent acceptance letter within one business day, ready for your records, importers, and FDA audits.
Communications Forwarding
Every FDA communication is received, reviewed, and forwarded to you promptly with plain-language summaries and recommended actions.
Renewal Reminders
Automated reminders ahead of annual and biennial renewal windows so you never miss a registration deadline.
Inspection Coordination
We serve as your on-the-ground contact during FDA inspections, coordinating schedules and facilitating communication with inspectors.
Dedicated Support
Direct access to compliance specialists who understand FDA regulations and answer your questions within hours.
What's NOT Included
These items are separate from your U.S. Agent fee. We can help you understand them, but they are billed elsewhere.
FDA's Own Fees
Device registration fees ($5,545+ per establishment), PDUFA fees for drugs, and other FDA-mandated charges are paid separately to the agency.
Legal Advice
U.S. Agent services do not include legal counsel. For regulatory disputes or enforcement matters, you may need separate legal representation.
Product Testing
Laboratory testing, stability studies, and product quality testing are not part of U.S. Agent services — these are separate compliance requirements.
Manufacturing Audits
FDA inspections, GMP audits, and facility assessments are coordinated through your U.S. Agent but are conducted by FDA or third parties.
How Assurentry Compares on Price
Many competitors charge $500–$1,500+ per year for U.S. Agent services and often add per-communication fees when FDA sends letters, notices, or inspection requests. Assurentry's $399/year flat rate includes unlimited communications handling, renewal reminders, inspection coordination, and same-day acceptance letters — with no surprise add-ons.
Common Questions About U.S. Agent Cost
Everything you need to know about pricing, payment, and what to expect from Assurentry's U.S. Agent services.
Get Your U.S. Agent for $399/Year
Appoint Assurentry as your FDA U.S. Agent. Transparent pricing, same-day acceptance letter, and dedicated support. No hidden fees.
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