FAQs
We help businesses around the world stay compliant with U.S. FDA regulations. Here are answers to some of the most common questions about our services:
Drug Establishment Registration
Who must register their drug establishment with the FDA?
Any domestic or foreign company that manufactures, repacks, relabels, or imports finished drug products into the United States must register its facility with the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 510 (21 U.S.C. § 360). This requirement ensures the FDA can identify and monitor drug facilities to protect public health. Registration is a critical first step toward legally marketing or distributing drug products in the U.S., and Hykkon helps simplify this process so your business remains compliant.
How often must I renew my drug establishment registration?
FDA drug establishment registration is not a one-time task. All registered facilities must renew annually between October 1 and December 31 each year to remain active in the FDA’s database. Missing this renewal deadline could mean your registration becomes invalid, leading to potential shipment delays, enforcement actions, or product holds at U.S. ports. At Hykkon, we actively track these deadlines and handle renewals on your behalf, giving you peace of mind that your registration stays current.
What is a Labeler Code, and do I need one?
A Labeler Code is a unique five-digit number assigned by the FDA that becomes the first part of your National Drug Code (NDC). You need this code if you plan to list and distribute finished drug products in the United States. Once you obtain a Labeler Code, it remains tied to your company, and you’ll use it whenever submitting new drug product listings. At Hykkon, we help clients apply for and manage their Labeler Codes correctly, avoiding errors that could slow down market entry.
Does Hykkon act as a U.S. Agent for drug establishments?
Yes. For foreign drug establishments, the FDA requires a designated U.S. Agent located in the United States to communicate with the agency on your behalf. Hykkon can serve as your official U.S. Agent, handling FDA inquiries, helping with inspection notices, and ensuring that time-sensitive communications from the FDA reach your team promptly and accurately.
Medical Device Establishment Registration
Who needs to register as a medical device establishment?
Any business that manufactures, sterilizes, relabels, repacks, imports, or distributes medical devices into the U.S. must register with the FDA under the FD&C Act Section 510 and 21 CFR Part 807. This includes both domestic and foreign facilities. Registration helps the FDA identify which facilities are involved in device manufacturing and distribution, making it easier to monitor safety and compliance.
What is a device listing?
In addition to registering your facility, you must list every medical device you manufacture or market in the U.S. Device listing includes details such as the proprietary name, common name, device classification, product code, and any relevant premarket submission numbers (510(k), PMA, etc.). At Hykkon, we help clients prepare and file these device listings to meet FDA requirements, ensuring the information is complete and accurate.
Is registration a one-time process?
No. Like drug establishments, medical device establishments must renew their FDA registration every year. The FDA’s annual registration period for devices runs from October 1 to December 31, and failing to renew can result in your registration becoming inactive, which may stop your ability to legally market devices in the U.S. Hykkon keeps track of these renewal periods and can file updates or renewals quickly on your behalf.
Prior Notice
What is Prior Notice?
Prior Notice is an electronic notice you must submit to the FDA before importing any food, beverage, or dietary supplement products intended for human or animal consumption into the United States. This requirement, part of the Bioterrorism Act of 2002 (21 U.S.C. § 381(m)), helps the FDA assess and mitigate potential security risks before shipments enter the U.S. Hykkon handles this process seamlessly, so your products aren’t delayed at the border.
When do I need to submit a Prior Notice?
You must file Prior Notice before your shipment arrives in the United States — ideally as early as possible after shipment details are confirmed. Late, incomplete, or incorrect filings can lead to costly shipment holds, customs delays, or refusal of entry. Our team at Hykkon makes sure your Prior Notices are submitted correctly and on time to avoid these issues.
Can Hykkon file Prior Notice for me?
Absolutely. We can prepare and file Prior Notices on your behalf, ensuring every detail aligns with FDA rules and reducing the risk of shipment delays or detentions. Our team has extensive experience filing Prior Notices for clients worldwide, giving you the confidence to keep your supply chain moving.
U.S. Agent & Compliance Services
What is a U.S. Agent?
For foreign food, drug, or medical device establishments, the FDA requires a designated U.S. Agent to act as the primary point of contact between your company and the FDA. The U.S. Agent must be located in the United States and is responsible for receiving inspection notices, answering compliance questions, and ensuring urgent FDA communications reach your team promptly. This role is critical to keeping your registration active and maintaining market access.
Can Hykkon review my product labels?
Yes. In addition to registration services, we offer optional label review to help ensure your product labeling complies with FDA regulations. Labeling mistakes can lead to enforcement actions, import refusals, or consumer complaints. Our compliance experts carefully check for mandatory statements, proper formatting, and any common issues that might cause delays at customs.
Does Hykkon charge hidden or extra fees?
No. We believe in transparent pricing. We don’t charge unexpected fees for routine registration updates, FDA communications, or minor amendments. If you request a premium service, like express document shipping (via FedEx or DHL), we simply pass along the carrier’s fee at cost without any markup. Clear pricing means you always know what to expect.
Is using an independent agent better than asking my importer?
Yes, and here’s why: while your importer might handle filings, this can blur roles and create conflicts of interest. As your independent U.S. Agent, Hykkon keeps your company’s compliance separate from your import contracts. This ensures your private business information stays confidential and that critical FDA communications reach you quickly. With our expertise and dedicated legal support, you can trust that updates, renewals, and emergency notices will be managed properly.
Do I have to commit to anything when I request information or a quote?
No. You’re under no obligation until you sign our service agreement. Any information you share to request a quote or review our contract remains confidential and is only used to help us assess your compliance needs.
Why do foreign food facilities need a U.S. Agent?
According to U.S. law, any food facility located outside the United States that manufactures, packs, holds, or processes food for human or animal consumption in the U.S. must appoint a U.S.-based Agent. This U.S. Agent acts as a liaison between the foreign facility and the FDA. The agent must be available to answer FDA inquiries and share urgent information quickly.
Hykkon takes this role seriously by providing reliable, responsive service every day, so you can focus on your business while we manage your FDA communications.
General Questions
Why do foreign food facilities need a U.S. Agent?
According to U.S. law, any food facility located outside the United States that manufactures, packs, processes, or holds food for human or animal consumption in the U.S. must appoint a U.S.-based Agent. This U.S. Agent acts as a liaison between the foreign facility and the FDA. The agent must be available to answer FDA inquiries and share urgent information quickly. At Hykkon, we take this role seriously by providing reliable, responsive service every day, so you can focus on your business while we manage your FDA communications.
What services does Hykkon offer for FDA food facility registration?
At Hykkon, we provide comprehensive support for businesses that must register food facilities with the U.S. FDA. Our services include acting as your designated U.S. Agent (as required by the FDA for foreign facilities), helping complete and file your initial registration, managing updates or amendments when your facility details change, and handling the mandatory biennial renewal process.
As a global compliance partner, Hykkon connects producers, growers, buyers, and consumers worldwide—streamlining FDA compliance while supporting international trade and distribution. By managing these complex requirements on your behalf, we help reduce risk, avoid costly delays at customs, and keep your products moving into the U.S. market smoothly.
What types of food products are covered under FDA facility registration?
FDA registration requirements cover a wide range of products meant for human or animal consumption in the United States. This includes fresh produce, processed foods, seafood, dairy, meat substitutes, baked goods, candies, dietary supplements, pet food, animal feed, and even additives like colors and preservatives. Alcoholic beverages such as wine, beer, and spirits are also generally included. If you’re unsure whether your product requires facility registration, Hykkon can help evaluate your product line and clarify your obligations.
Which food facilities are exempt from FDA registration?
Some facilities are exempt, such as:
- Farms that only grow or harvest food without processing it for off-farm sales.
- Retail food stores, restaurants, and non-profit food establishments.
- Facilities handling food destined for further significant processing at another foreign facility.
- Facilities regulated exclusively by the U.S. Department of Agriculture (e.g., most beef and poultry plants).
- Transport vehicles used only for moving food.
If your operations might qualify for an exemption, Hykkon can help you determine this and document it properly to reduce compliance risks.
When must food facilities register or renew with the FDA?
Foreign and domestic food facilities must complete registration before shipping food into the United States. After the initial registration, the FDA requires facilities to renew their registration every two years (biennial renewal) during an even-numbered year, typically by December 31. Facilities must also update their registration within 60 days of certain changes, such as a change in ownership or address.
At Hykkon, we proactively track these deadlines for our clients to help prevent lapses that could delay shipments or trigger penalties.
What happens if I fail to register or renew on time?
The consequences can be serious. The FDA can consider your registration inactive, and shipments may be detained at the port of entry, leading to delays, additional storage fees, or spoilage of perishable goods. Repeated non-compliance could also lead to fines, import bans, or legal action. Hykkon helps prevent these risks by actively monitoring your registration status and handling renewals on your behalf.
Does it take a lot of time to register?
While the FDA registration form can be complex, requiring over 180 data fields, Hykkon streamlines the process. Our guided workflow typically takes about 30 minutes of your time to provide the needed details. After that, we manage the preparation, submission, and follow-up directly with the FDA. This reduces administrative burden so you can stay focused on your core business.
What information do I need to provide for registration?
To complete your FDA registration, we’ll typically ask for:
- Your facility’s name, address, and contact details
- DUNS or EIN number (if applicable)
- Business type (manufacturer, packer, relabeler, importer, etc.)
- S. Agent or importer information for foreign facilities
- Product details, including classifications, codes, or drug/medical device status
Providing accurate and complete data from the start helps us submit your registration quickly and reduces the chance of delays.
How long does the registration process take?
With complete information, Hykkon can often finalize your registration within just a few business days. Exact timelines vary by product type and whether additional steps (like FDA labeler code approval or device listing) are required, but our goal is always to help you enter the U.S. market as fast as possible.
What payment methods do you accept?
We accept most major credit cards (Visa, Mastercard, American Express, Discover) and wire transfers. Note that FDA registration fees themselves must be paid directly to the FDA, but our service fees can be paid through these secure options.
Still have questions?
If your question isn’t listed here or you’d like tailored guidance, our compliance specialists are ready to help.
Contact us or call anytime.
We’re here to keep your products compliant and your business moving.
