What a U.S. Agent is not?
- Commercial Agent
- Customs Broker
- Initial Importer
- Importer of Record
- FSVP Importer
The User Fee programs help the Food and Drug Administration (FDA) fulfill its mission of protecting the public health and accelerating innovation in the industry.
List of fees covering Annual Establishment Registration and or filing of an Application:
Accredited Third-Party Certification Program User Fees
Animal Drug User Fee Act (ADUFA)
Animal Generic Drug User Fee Act (AGDUFA)
Biosimilar User Fee Amendments
Color Additive Certification Fees
Export Certificate Fees
Freedom of Information Act Fees (FOIA)
Generic Drug User Fee Amendments
Human Drug Compounding Outsourcing Facility Fees
Mammography Facility Fees (MQSA)
Medical Device User Fee Amendments (MDUFA)
Over-The-Counter Monograph User Fee Program (OMUFA)
Prescription Drug User Fee Amendments
Voluntary Qualified Importer Program User Fees
Current User Fee for Medical Device Establishment Registration is $5,546.00 until September 30, 2021.
$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021). This new fee is additional and required. Manufacturers of hand sanitizers and alcohol wipes are currently exempt.
Just you know, we do speak more than 5 languages.
- FDA Registration Number
- U.S. Agent Service
The global personal protective equipment (PPE) market is expected to reach nearly $13.2 billion by 2027.
Is your company manufacturing, exporting, importing, distributing the following products, instead?
- N95 Respirators and Surgical Masks
- Face shields, isolation gowns, goggles, gloves
Annual User Fee is required and extra: $5,546.00.
Global Hand sanitizer market valuation to reach $17.2 billion by 2026.
The growth is primarily attributed to rising prevalence of COVID-19, supportive regulatory scenario which promote the use of the product, and increasing awareness pertaining to personal hygiene.
Are you ready to meet the supply challenge?
Your first step is the registration of your company as OTC Drug Establishment with the U.S. Food and Drug Administration.
User Fee is not required, at this time.