U.S. FDA Registration Timeline: How Long Does It Actually Take?

The U.S. FDA Registration Timeline generally takes a few business days once all your information is ready. However, “a few business days” is not the whole process. You may first need to appoint your U.S. Agent, prepare your DUNS/UEI number, and make sure your FURLS filing does not get delayed or returned because of mistakes. 

This guide will help you understand the FDA registration timeline, as it really goes step by step.It will also help you to understand what factors can affect the FDA processing time in each of these steps and provide you with a realistic timeline – either when you are going to register a new food facility or if you are confused about the stuck registration submission.

What Is the U.S. FDA Registration Timeline

U.S. FDA Registration Timeline refers to the period beginning from the start of your facility registration process until you receive confirmation of your registration number from the FDA’s Food Facility Registration Module (FURLS). For a well-prepared facility, the process itself should take 3 to 5 business days – all the delays occur prior to this.

It is important to note that U.S. FDA registration is a mandatory requirement for exporting food products to the U.S. market according to the Food Safety Modernization Act (FSMA). Without the registration number, you will not be able to get your shipment past U.S. customs.

U.S. FDA Registration Timeline: Step-by-Step

How long does U.S. FDA Registration take from start to finish? It depends on which of these four stages you’re moving through.

Step 1: Gather Facility and Product Information

The exporter must have information regarding the legal name of the facility, address, and product categories (in terms of FDA Product Codes). For many exporters who have such information ready, this process will take 1 to 3 days, but for those who do not have the DUNS/UEI number, another 3 to 5 days will be needed.

Step 2: Appoint a U.S. Agent

FDA requires that each foreign establishment wishing to register with FDA should appoint an U.S. Agent – a person or organization physically located in the U.S., whom FDA would approach. The process of confirming the U.S. Agent and obtaining written consent usually takes between 1 to 2 days if the compliance partner is already known; otherwise it will take more time.

Step 3: Submit Registration via FURLS

Registration is made by filing through the FDA’s electronic registration portal known as the Food Facility Registration Module. This takes 3 to 5 days if there is no mismatch in data in the application form. However, mistakes like your name not matching the DUNS record or the lack of your U.S. Agent verification will cause it to be returned to you.

Step 4: Receive Registration Number and Confirmation

When your application is approved, the FDA assigns you a registration number and confirms that, which will be used by you to file for Prior Notice as well as import into the US. There is no additional waiting period after your application is approved.

How Long Does U.S. FDA Registration Take? Quick Answer

For food establishments specifically, the time taken for the process of U.S. FDA Registration is done within this timeframe – the registration requirements under FSMA do not allow for a longer or shorter statutory review timeframe for food establishments.

Factors That Affect FDA Registration Processing Time

• DUNS/UEI number status – A new facility with no DUNS number takes the longest time among all
• Product Classification Codes – If the codes provided are not accurate, then the application gets delayed
• Responsiveness of U.S. Agent – The FDA may get in touch directly with the agent, and any delay in response will delay processing
• Consistency in Names and Addresses – Any inconsistency between the information you have in your application and elsewhere in the United States is a frequent reason for rejection
• Even Year Window Period – Applications submitted from October through December of the even year are often delayed due to large numbers

FDA Registration Timeline vs Biennial Renewal Timeline

Initial registration and renewal aren’t the same process, and confusing the two is a frequent source of missed deadlines.

How to Speed Up Your FDA Registration

1. Get the DUNS/UEI number prior to filling out the FURLS application, and not while doing it.
2. Verify in writing your U.S. Agent agreement ahead of time, so that it won’t delay because of their approval.
3. Ensure accuracy of product code in FDA’s classification list, and not rely on the code from a similar product.
4. Make sure that your facility name and address are correct on your DUNS number and registration form as well as your FSVP document.
5. If possible, avoid filling the renewal application in the period from October to December in even years.

Common Mistakes That Delay Registration

• Starting the FURLS application process before the DUNS/UEI is verified
• Selecting a U.S. agent without checking to see whether they will communicate with the FDA
• Registering using a trading name which does not correspond to your official company records
• Thinking that FDA registration is the same as FDA approval — the former does not require the examination of products, while assuming it is a more involved process is a waste of time
• Not registering until the order is confirmed, thus making no room for correction cycles

Key Takeaways

• The timeline for FDA registration in the United States is 3 to 5 business days if submission information is correct – delays occur mostly in the process itself, not in FDA’s evaluation of it.
• The lack of DUNS/UEI code or lack of confirmation of US Agent is the two most common reasons that registration takes longer than anticipated.
• Timeline for the FDA registration process of food facilities is similar to the timeline for any other facility under FSMA.
• The biennial renewal (Oct 1 – Dec 31 of even years) is processed separately from the initial registration and comes with its own deadlines.
• Having product codes, company name, and address matching each other across all submitted documents is the key factor for quick and efficient registration.

Conclusion

But the vast majority of the U.S. FDA Registration Timeline is actually going to be in your hands. And once the application is in order, FDA review is quite quick; how long your waiting time will take depends on how prepared your DUNS/UEI, your designation of a U.S. agent, and your product categories were when you applied.

Taking a few additional weeks to prepare ahead of the export deadline, versus leaving everything to the last minute, is the difference between a timely registration and a delayed shipment. This is exactly the type of buffer that we include in all of our registration timelines for our clients at Legal4sure.