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Gowns, gloves, face shields, goggles, facemasks and respirators are Medical Devices. Therefore, an FDA User Fee of $5,672.00 is required for the annual Establishment Registration (Fiscal Year 2022).
Some devices are subject to Premarket Notification 510(k) – Standard Fee: $12,745.00. Small Business Fee: $3,186.00 (Fiscal Year 2022).
$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
User Fees are paid to the U.S. Treasury.
- Company Registration
- U.S. Agent Service
Prior Notice, Label Review or Update, Foreign Supplier Verification Programs (FSVP), are available for extra fee.