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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).
In order to register your establishment and list your hand sanitizer, only our annual fee of $350.00 is needed. Hand sanitizers are OTC Drug Products.
$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2021) is required for all other OTC drug products.
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.