- Company Registration
- U.S. Agent Service
- Available for additional fee:
*Label Review or Update
*Certificate of Registration
- Surgical Masks
- N95 Respirators
- Gowns, Face Shields, Gloves, Goggles
FDA Medical Device Establishment registration fee for Fiscal Year (FY) 2022 is $5,672. FY 2022 starts on October 1, 2021 and ends on September 30, 2022. Annual establishment registration fee must be paid between October 1, 2021 and December 31, 2021.
- Alcohol Hand Sanitizers
- Alcohol Wipes
- Antidandruff shampoo, Toothpaste containing fluoride, Antiperspirant deodorant, Cold and cough products, Skin Protectant, Sleep Aid, Topical Analgesic, Weight Control
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.
Dietary Supplements Facility
Food Canning Establishment (FCE)
OTC Drug Establishment
Prescription Drug Establishment
Medical Devices Establishment
OTC Cosmetics Establishment
Foreign Supplier Verification Program (FSVP) Importer
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.
■ Annual for Medical and Drug Establishments
■ Biennial for Food Facilities
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.
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