- Company Registration
- U.S. Agent Service
- Surgical Masks
- N95 Respirators
- Gowns, Face Shields, Gloves, Goggles
User Fee is required and extra: $5,546.00 | Medical Device Establishment Registration (FY 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.
- Alcohol Hand Sanitizers
- Alcohol Wipes
FDA REGISTRATION requests must include:
- Full company name
- Complete physical address
- First and last name of CEO or Manager
- Email and telephone of CEO or Manager
- Product details
- Company DUNS Number
Data Universal Numbering System, DUNS or D-U-N-S from Dun & Bradstreet Inc. Free in 30 days or for a fee in 15 days.
Keep in mind that all domestic and foreign companies must have a DUNS Number. Therefore, requesting one now or as soon as possible, is in your company’s best interest.
FDA automatically performs a DUNS check during the registration process. So, make sure your company’s name and physical address match D&B’s records.
PayPal, Local European Payments
Debit and Credit cards
Bank Wire Transfer.
U.S. Department of Treasury
33 Liberty St
New York, NY 10045
Account Number: 75060099
Routing number: 021030004
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002
FDA’s Tax Identification Number: 53-0196965.
$5,546.00 | Medical Device Establishment Registration (FY 2021, from October 1, 2020 to September 30, 2021)
The preferred payment methods are
- electronic check (Automated Clearing House – ACH also known as eCheck)
- credit or debit card (Discover, VISA, MasterCard, American Express).
Payment by credit card is available for balances less than $25,000.
FRANÇAIS | FRENCH
ESPAÑOL | SPANISH
DEUTSCH | GERMAN
Sprichst du deutsch?
NEDERLANDS | DUTCH
Spreek je Nederlands?