The Complete Guide to FDA Customs Clearance

If your business imports goods into the US, you'll likely run into the rules surrounding FDA customs clearance. These rules and regulations are often much more complex than you might have thought, so it is something that you should look into if you want to make sure that you are following the rules properly. In this article, you will find a complete guide to FDA customs clearance, including everything that you need to do and be prepared for in the process.

Although FDA customs clearance can be complex, we aim to simplify it and break it down for you. Here’s all you need to know about the rules and processes involved. With this information on hand, you will be able to import goods into the US with ease.

Import Process For FDA Regulated Products

If you are importing any goods into the US for your business, first you are going to need to be aware of the overall import process for FDA regulated products. The process is simple enough once you know it and have it broken down, but until that has happened you might find yourself feeling a little perplexed around the whole thing. With that in mind, let’s look now to the import process for FDA regulated products.

All products regulated by the FDA need to be reviewed by the FDA when they are coming into the U.S. All entries that are submitted through the U.S. Customs and Border Protection (CBP) are reviewed electronically by the FDA. Essentially, in this process they are checking that those products comply with all of the FDA’s laws and regulations. The importer is ultimately responsible for ensuring that the products are following all laws and regulations.

The first step in the process is to use the services of a customs broker, who are the only people authorized by law to act as agents for imported goods. They will arrange the payment of duties, file the necessary customs entries, and represent you in various other matters besides. When the entry is made with the CBP, you or the customs broker will have to include the Harmonized Tariff Schedule (HTS), which includes tags that help the FDA to determine whether specific data is required or not. If the HTSUS code shows that a product is regulated by the FDA, then the submission of necessary information has to happen at that point.

What Products Are Regulated by the FDA?

Not everything that you might import is regulated by the FDA, so it’s good to be fully aware of the ones that are. The FDA regulates many products of many different kinds, most notably foods and drugs, vaccines, biological products, medical devices to be used by humans radiation-emitting products, cosmetics, dietary supplements, and tobacco.

In recent years, the majority of products regulated by the FDA that were imported came under the heading of ‘devices’, at 48% of all the imported goods of this kind. After that, the next most common type of product was human food at 31%.

If you are ever unsure about what kind of products you think need to be regulated, and which don’t, you can always check online at the FDA’s website or another trusted source - or ask your customs broker for an extensive list and to help you with a specific query. Generally, if what you are importing is to be consumed, used on humans or animals, or it’s one of those other slightly more obscure types, then you will probably need to submit it to the FDA for approval during the customs process.

Do I Need to Register With The FDA?

When you are importing goods into the US, you might wonder whether it is important to register with the FDA. As it happens, there are various kinds of registrations that need to occur, and it’s a good idea to be fully aware of these before you actually get the process going. It is an important part of the administration side of importing goods, and something which you can’t overlook. So what kind of registration do you need to partake in, and how do you actually go about doing so?

How to register depends on what type of product you are importing, so let’s take a look at some of the most common ones.

Animal & Veterinary

If you are importing any animal products which are to be used as drugs and other such items, you do need to register these with the FDA. Domestic and foreign drug manufacturers also have to list all of their commercially available products.

Cosmetics

For cosmetics, you should refer to the Voluntary Cosmetic Registration Program, an FDA post-market reporting system which is used by many manufacturers and distributors in cosmetics for approval.

To learn more about importing cosmetics, check out our article Importing Cosmetics to the U.S.

Drugs

If you are to manufacture, re-sell or re-label drugs of any kind, then you need to register with the FDA first. You also have to list all of your commercially available drug products, which is supposed to help the FDA to keep a tally of what drugs are actually out there at any one time.

Our blog importing pharmaceuticals into the U.S., provides detailed information on all of the requirements in place.

Food

All food distributors and operators and agents must register with the FDA if there is to be any movement of any part of the food over the border. This includes the import of beverages as well, like coffee and water bottles.

Medical Devices

Owners or operators of places of business which operate in the production or distribution of medical devices for use in the US are required to register with the FDA.

Radiation-Emitting Products

Filing Radiation Safety (Product) Reports for any radiation-emitting product is something that you have to do by law. This information has to go through the FDA too.

Tobacco Products

Anyone who owns or operates any establishment engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product has to register the premises with the FDA every year. You also have to submit a list of all the tobacco products which are being manufactured.

Biological Items

Anyone who is involved in creating or using human cells, tissue, and cellular and tissue-based products needs to register with the FDA. The same is also true of blood and blood collection, and anything to do with vaccines.

As the Importer of Record, it's your responsibility to ensure that you've properly register with the FDA. For more information, on this topic checkout our article on Importer of Record.

How to Register With The FDA

In order to register for various products with the FDA, you have to follow some specific processes. Let’s take a look at those now, to ensure that you know what you are doing in each case.

Animal & Veterinary

You need to register the establishment involved in the products, and also list all of your commercially marketed drug products. This process is done in conjunction with the human drug registration process.

Cosmetics

You should use the Voluntary Cosmetic Registration Program (VCRP) as outlined above.

Drugs

Register with the FDA in the normal way, but also list all of the drugs that you sell commercially as a publically available document.

Food

Register your facility with the FDA, and also give advance notice to the FDA of incoming shipments of food.

Medical Devices

Register annually with the FDA - a process known as establishment registration. The annual registration user fee for 2020 is $5,236.

Radiation-Emitting Products

Use the Filing Radiation Safety (Product) Reports as outlined above, and consider using the electronic templates available in eSubmitter.

Tobacco Products

Follow section 905 of the Tobacco Control Act, and ensure that you register annually by the 31st of December. Also supply a full list of all tobacco products you sell. You can register electronically using the FDA Unified Registration and Listing System (FURLS).

Biological Products

Register with the agency and provide a list of all of your HCT/Ps.

Class 1, 2, and 3 Medical Device Classifications

When you are submitting to the FDA for medical devices, you need to make sure that you are aware of how the different classifications work. The FDA has established classifications for around 1,700 different types of devices, grouping them into 16 medical specialties known as panels. Each type is then assigned to one of three classes, based on the level of control required to ensure the safety of the device.

The three classes and the requirements which apply to them are as follows:

1. Class I General Controls

• With exemptions
• Without exemptions

2. Class II General Controls and Special Controls

• With exemptions
• Without exemptions

3. Class III General Controls and Premarket Approval

To determine the type of premarketing submission and application required for FDA clearance to market, the class to which you device belongs must be determined. For devices classified as I or II, and not exempt, a 510k is required for marketing.Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a pre amendments device.

It’s worth noting that the classifications depend on the intended use of the product, and indications for use. To work out the classification of any device, you need to look into the regulation number that is the classification regulation for the device in question. You can do that through the classifications database. That will then show you what the classification of the device is.

What is a 510 K Premarket Notification and When is it Required?

Anybody who wants to market a Class I, II or III product intended for human use in the US, where a Premarket Approval application (PMA) is not required, must submit a 510(k) to the FDA unless the device is specifically exempt and does not exceed the limitations of exemptions.

Essentially, a 510(k) is a premarket submission made to the FDA which demonstrates that the product in question is safe and effective. Submitters have to compare their device to one or more similar legally marketed products already in circulation and support their claims in that and other ways. This is a vital part of all FDA customs clearance.

Do I Need to Submit a Premarket Approval (PMA)?

The Premarket Approval (PMA) is another important part of the FDA customs clearance process when it comes to the Class III medical devices. It is the FDA process of scientific and regulatory review, to help ensure that those devices are safe and effective. Generally, Class III devices are those that support human life or sustain it, are considered important in preventing impairments to human health, and other products of that nature. All these products require a PMA.

When a PMA is Required

PMA requirements apply to all Class III medical devices. To determine whether your device is Class III, see above for more information. If you are at all unsure as to whether a device requires a PMA, you can use the three letter product code to search the Premarket Approval (PMA) database and the 510(k) Premarket Notification database.

It is also worth noting that sometimes a new device won’t be found in the product classification database. If the device is high risk (pertaining to maintaining or upholding human life) and has been found not to be substantially equivalent to an existing Class I, II or III device, then the device has to have a PMA before marketing in the US.

Cost to Import FDA Regulated Products

Whenever you are looking to import FDA regulated products, one of the main concerns you will likely have as a business owner is how much it is likely to cost you. If you are not aware of this, then it will make it much more difficult to plan, and the future of your business could be at risk. However, it’s not always too simple to say just how much it might cost to import FDA regulated products, and one part of FDA customs clearance is ensuring that you have looked into this as best as you can, with as much detail as possible.

The main thing to remember is that the cost of importing FDA regulated products into the US varies greatly depending on a variety of factors. One of the main factors that can make a difference to cost is the type of product that you are importing. Different product types are always going to cost different amounts to import based on their size, constitution and so on, so you need to be aware of that.

At the same time, the value of those products is also going to have an impact on the cost of importing. Higher value products are obviously generally going to cost more. You can therefore get a good sense of the cost of importing a specific product by thinking about what its value is, and determining it that way.

You will also find varying costs depending on the length of time you have been in business. The longer you have been in business, the less likely it is that you will have to pay too much upfront, and you will probably also be in a better position generally, so that is something to bear in mind. New businesses sometimes struggle with the costs, especially if they have not actually prepared for it all that well. As well as all of these things, there are many other factors that might make a difference to how much it costs you to import products into the U.S. through the FDA’s procedures.

Importantly, remember that a new business hoping to sell a brand new product will face a much higher cost, so it’s something that you are going to have to prepare for as best as you can. There are some specific costs to importing a product which you should be aware of in as much detail as possible, including a customs bond, duties, and of course the cost of shipping itself, which can be significant in any case. The duties will also vary based on the type of product and country of origin. For all these reasons, it’s hard to give an overview of what you might expect to pay, but you should make sure to do your research and work it out as well as you can before going any further with your business.

One of the ways to reduce costs when importing FDA regulated products is to see if they can be sourced from countries that hold an active Free Trade Agreement. Take a look at our article on U.S. Free Trade Agreements for more information.

Common FDA Customs Clearance Mistakes

As with pretty much any process in the world of business, there is always going to be the possibility that you will make a mistake. These mistakes can generally be avoided, however, if you know what they are beforehand and you work hard to make sure you don’t fall into those traps. Let’s take a look at some of the most common types of FDA customs clearance mistakes, and how you might be able to avoid them in the future.

• Submitting incorrect Affirmation of Compliance (AofC) information. This information is supposed to affirm that the product in question meets requirements specific to the product. Submitting the wrong information could delay screening and review significantly. A little extra care on the administrative side of things is all you need to avoid this error for yourself.
• Submitting incorrect manufacturer information. This is probably the single most common error that is made during the FDA customs clearance process. The FDA requirement can often differ from the CBP one, so it’s easy to get them confused. This could mean that your shipment is held longer than strictly necessary for a further review. Again, ensuring that you take extra care will help to avoid this issue.
• Submitting the incorrect product code. This is one of those simple, easy mistakes to make which can cost you dearly in time and money. An error in just one element of the code could mean that products end up in the country which do not adhere to the FDA’s rules and regulations. Slow down and triple-check the product code before submitting.
• Submitting the incorrect quantity. The quantity is obviously important to know, as it ensures that there is the appropriate shipment amount each time. When submitting this information, be aware that basic format for quantity data is in multiple pairs of data. Get this right to avoid some very problematic waiting times for everyone involved.
• Submitting the incorrect shipper information. The FDA needs to know the firm that is involved in the actual shipment, and if this is wrong then it could mean that there are huge delays in the shipment itself.
• Submitting an inaccurate or incomplete description. This information should be aiding the FDA in checking an entry, and if it is wrong then it can cause confusion and delays, and could mean that non-FDA approved products end up circulating.
• Submitting the incorrect device initial importer. As above, your product may be held for unnecessarily long if you fail to get this right, so extra care is required in order to avoid that issue.
• Submitting the incorrect consignee. Without this, the FDA doesn’t have the right information on where in the US the shipment is going.
• Incorrect grouping of line items. When this happens, a new entry may be required to ensure that the products are grouped into line as they should be. Make sure that you are fully aware of how they are meant to be grouped before attempting to provide this information.

As you can see, there are many problems and errors that can occur, and you need to make sure that you are doing everything you can to avoid those issues. One of the best ways to do that is to work with an experienced and knowledgeable customs broker, who can ensure that these mistakes are avoided in the first place.

How to Handle an FDA Customs Hold?

From time to time, you might have a shipment detained by the FDA as a part of the FDA customs clearance process. That might happen as a result of any of the above errors, a different error on your part not already listed above, or occasionally an error by the FDA. At other times still you will find that there is a completely unrelated issue which has caused your shipment to get caught up, so there’s not much that can be done about that.

Whatever the cause, essentially when this happens it means that the FDA is taking a further investigation into your shipment, and it is good to know how you should best handle this process. If you act properly, you will put yourself in a much better position with the FDA, which is always going to be a good idea.

Firstly, gather the facts about the detention. Rather than assuming you know what is going on, make sure you are told everything you need to know, so that you know how to act going forward. It’s especially important that you don’t argue with the FDA inspector who detained your shipment. Similarly, do not respond at all until you have gathered all of the details you possibly can. If you are concerned about the shipment, for instance it has great value, you should think about retaining a professional consultant familiar with the FDA and its procedures, to help you.

After detaining your shipment, the FDA will submit a written document to you called the Notice of Action, or to your customs broker if you used one. This will lay out the formal reasons why the shipment was detained. You must respond to these detention charges with proof that you have documented. There will be a deadline on the document by which you have to respond.

Check out our article on customs examinations for more informations on how to handle this difficult situation.

How to Expedite the FDA Customs Clearance Process

If you are wondering what you might be able to do in order to speed up the FDA customs clearance process, there are actually some options. There are many occasions when you might find you want to do this, and it’s good to know that you absolutely can do so. Generally, the best way to expedite the process is to use The Voluntary Qualified Importer Program (VQIP).

Essentially, the VQIP is a voluntary fee-based program that allows the review and import entry of human and animal foods into the US to be expedited. Used properly, consumers and importers alike will benefit from the program, as you can probably see already. This allows you as the importer to import goods into the US at a much greater speed, and to a higher degree of predictability too. It helps you to avoid unwanted or unexpected delays at the border, which is always going to be helpful.

In order to make use of the VQIP, you have to meet the eligibility criteria for it, and pay a fee that covers the cost of the FDA’s administration of the program itself. If you are interested in using this program, you can submit a notice of intent to participate by setting up an account via the FDA Industry Systems site.

Using this program could make a world of difference to how quickly and efficiently the import process is for you, which could in tuen translate to happier customers and a healthier business in the future. It’s well worth considering.

How Can a Customs Broker Help With FDA Customs Clearance?

Whatever it is that you are going to be importing, you need to make sure that you are getting it right. That means paying close attention to all of the above, doing whatever you can to keep things in order and on track, and also making use of whatever help you can find too. One of the most important kinds of help you might want to look to is a customs broker, who can assist you with all aspects of the FDA customs clearance process.

Specifically, a customs broker can:

• Determine if your product is FDA regulated.
• Determine appropriate Harmonized Tariff Schedule (HTS) codes, which are required by CBP.
• Inform you of the required FDA information, and affirmations of compliance.
• Obtain a bond to cover the entry.
• Provide all documentation to the FDA.
• Transmit required entry information using ABI.
• Enter a product’s affirmation of compliance information, thus expediting the review.
• File Prior Notice.

They can also more generally help you with any questions or concerns you might have about any of the above, or anything else related to FDA customs clearance. If you want help with any of that, you should seek out an experienced and dedicated customs broker.

Get The Help You Need Importing FDA Regulated Goods

If you do decide that you need assistance and advice when dealing with the FDA customs clearance process, then you need to look towards a good customs broker. That means a broker who is experienced, dedicated and fully knowledgeable of everything that needs to be done in the process. If you are looking for that, you need look no further than USA Customs Clearance.

We offer a wide range of services related to FDA customs clearance and customs brokerage in general.

Our services include:

• ISF Filing
• Tariff Classification
• Duty Drawback
• Section 301 Support
• And more...

In addition to our customs brokerage services, we provide countless supply chain services as well. This includes warehousing, domestive & international transportation, order fulfillment, and more. This comprehensive approach allows us to serve as your one-stop shop for all of your supply chain needs.

When you're ready, purchase your annual customs bond or schedule your import consulting session. Our team is ready to help you successfully navigate the FDA customs clearance process.