- Switch U.S. AGENT Deals
- No hidden costs
- No forced options
- Only what you need or want
- Reduced fee for multiple services
- Reduced fee for multiple companies
- U.S. Agent Service included
- Same Day Service for extra fee
- Company Registration
- U.S. Agent Service
Prior Notice, Label Review or Update, Foreign Supplier Verification Programs (FSVP), are available for extra fee.
User Fees are paid to the U.S. Treasury.
Gowns, gloves, face shields, goggles, facemasks and respirators are Medical Devices. Therefore, an FDA User Fee of $6,493.00 is required for the annual Establishment Registration (Fiscal Year 2023).
Some devices are subject to Premarket Notification 510(k) – Standard Fee: $19,870.00. Small Business Fee: $4,967.00 (Fiscal Year 2023).
$16,119 – $24,178 | Over-The-Counter Monograph Drug User Fees (OMUFA) (FY 2022)
- Monograph Drug Facility (MDF) Facility Fee: $24,178
- Contract Manufacturing Organization (CMO) Facility Fee: $16,119
are now required to register an establishment manufacturing, among other products,
- Antidandruff shampoo
- Toothpaste containing fluoride
- Antiperspirant deodorant
- Cold and cough products
- Hand sanitizers