Prior Notice
Get Your Medical Devices Cleared for the U.S. Market
To legally import human and animal food, beverages, and dietary supplements into the United States, the U.S. Food and Drug Administration (FDA) requires that you submit a Prior Notice (PN) before your shipment arrives.
This requirement, established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (commonly called the Bioterrorism Act, codified at 21 U.S.C. § 381(m)) and detailed in 21 CFR Part 1, Subpart I, helps the FDA evaluate shipments before entry to protect public health and ensure food safety.
Failure to submit accurate and timely prior notice can lead to shipment delays, refusal of entry, or even product destruction.
What is Prior Notice?
Prior Notice must be filed electronically through FDA systems (Prior Notice System Interface or Automated Broker Interface) before food products are imported or offered for import into the U.S.
This applies to:
- Human and animal food
- Beverages
- Dietary supplements
- Bulk food ingredients and finished products
What We Offer
At Hykkon Global Logistic Group, LLC, we help businesses stay compliant by preparing and submitting your FDA Prior Notice accurately and on time.
We also provide:
- Drug Establishment Registration
- Labeler code requests and SPL preparation
- Drug Listing submissions
- S. Agent representation
- Optional label review for compliance
What You'll Need to Provide
To complete prior notice and related FDA submissions, we typically need:
- Establishment name, address, and DUNS number
- Type of operation (e.g., manufacturer, API manufacturer, relabeler, repack, sterilizer)
- Contact details of the establishment and submitter
- S. importer/distributor details, including FDA registration number and DUNS
- Drug or food status (OTC, prescription, veterinary, homeopathic, etc.)
- Details about the product being shipped
Service Options & Fees
- Drug Establishment Registration – USD 649 annually
- Labeler code / SPL preparation – USD 399 per drug
- Drug Listing – USD 649 per drug
- Optional label review – additional fee
All fees are paid annually or per submission, as needed.
Ready to file your Prior Notice or register your establishment?
Complete the form below and let Hykkon handle the FDA process quickly and accurately.
We’ll help keep your shipments compliant, avoid costly border delays, and get your products to the U.S. market smoothly.
