Enlisting an FDA US agent is a basic requirement for importers of FDA-regulated products. US agents are the frontlines of communication with FDA, assisting with submission of required registrations and listings as well as support with questions posed by the Agency on imported products. At a minimum, FDA US agents must provide basic services stipulated by FDA, but US agents can also be much more, facilitating registrations in the FURLS database, assisting with FDA inspection preparation and more.
With all the challenges to importing products into the US, and with so many firms positioning themselves as offering US agent services, choosing one with the right expertise and level of responsiveness will go a long way when working with FDA.
The Basics – FDA US Agent Requirements
Though the requirements of an FDA US agent’s services are straightforward, the decision of which US agent to choose can be monumental for a foreign establishment. In some cases, foreign establishments are comfortable working directly with FDA and are designating a US agent just to meet FDA’s basic requirement. Other foreign establishments look to their US agent to provide guidance and expertise on FDA regulations and imports.
The most basic US agent services include:
- Assisting FDA in communications with the foreign establishment, particularly when FDA is unable to contact the foreign establishment directly or expeditiously
- Assisting FDA in scheduling inspections of the foreign establishment
Who Can be an FDA US Agent?
For starters, FDA will only accept designated US agents that reside in the US and receive mail at a physical address. The US agent must also have someone available to answer the phone during business hours. Post office boxes and answering services are not permitted.
FDA considers information or documentation provided to the US agent equivalent to providing them to the foreign establishment. So, it is important to choose a US agent that understands their responsibilities both to FDA, and to you. Timely two-way communication with FDA is critical to ensuring smooth business and imports. FDA will always provide deadlines by which they expect responses to their requests. When US agent communication is delayed, your business can be negatively affected.
The Partnership – FDA US Agents with Regulatory Expertise
Foreign establishments looking for support beyond the basic US Agent requirements may find this in consultants who provide layers of expertise and service. Ensure as you weigh the benefits of any additional services provided by US agents that their expertise is relevant to your business. Choosing an expert in pharmaceutical imports, for instance, may not be of benefit to an importer of food.
Choose an Agent With FDA Unified Registration and Listing System (FURLS Database) Experience
In addition to facilitating communication between the FDA and a foreign establishment, FDA US agents with relevant regulatory expertise can also provide guidance about FDA requirements. For example, foreign establishments are required to register the facilities in which their products are made with FDA via the FDA Unified Registration and Listing System (FURLS database). US agents with FURLS accounts and who understand how to navigate the FURLS database system may be able to provide that service.
Your FDA US Agent Should Understand the Voluntary Qualified Importer Program (VQIP)
Importers who demonstrate exemplary records of safety, including suppliers, may be eligible for FDA’s VQIP, a pay-to-play program that expedites food imports. Knowledge of the VQIP program and its benefits as well as the ability to assess supplier documentation for eligibility consideration may be of interest when choosing your US Agent. Applications and eligibility into the VQIP program are arduous. An FDA US Agent with knowledge of this program will help you determine if it is right for your business.
Know How to Prepare for FDA Audits and Inspections
FDA’s routine, random and for-cause inspections cause angst for any company, both inside the US and out. US Agents with histories of successfully navigating FDA inspections in your commodity area and former FDA inspectors or investigators who previously conducted these inspections can be instrumental in helping you prepare.
- Are your SOPs thorough and documented?
- Are your batch records and change control adequately recorded?
- By what measures do you vet your suppliers to ensure their compliance with FDA regulations?
- Is your facility maintained in a manner commensurate with the Good Manufacturing Practices (GMPs) established by FDA for your type of products?
These are just a few of the many questions you may have regarding compliance with FDA regulations. Whether your FDA US Agent is a regulatory expert and able to provide assistance in these areas or you seek assistance elsewhere, your ability to import FDA-regulated products into the US will depend on these and other criteria.
Designating Your US Agent in the FURLS Database
As part of the registration process, the foreign establishment is required to notify FDA of the US agent’s contact information, including name, address, telephone and fax numbers, and email address. For medical device registrations, the foreign establishment has the option to also designate the US agent as its official correspondent. Once FDA has been notified of the US agent, the agent identified will have a finite number of days to complete an automated process sent via email by FDA to confirm their consent to act as a representative/liaison on behalf of the foreign establishment (30 days for food facility confirmations, 10 days for medical device confirmations).
If there is a change to the US Agent, including basic contact information, FDA must be notified within 30 days. In the event a new US Agent is designated, that new US Agent must also submit to FDA their consent to act as the foreign firm’s liaison.
Should FDA determine that documentation provided by the foreign establishment about a US Agent is inaccurate, incomplete, or that the US Agent does not meet FDA’s residential requirements, FDA will send a Deficiency Letter to the foreign establishment requesting specific corrections to be made within 30 days.
Managing FDA imports is a serious business, and the effectiveness of an FDA US agent can make or break a foreign establishment’s ability to work with FDA and sell products in the US. Decide in which areas you would like additional assistance, and if you would like that assistance to be provided by your US agent. Then ask questions of those US agents that you are considering. You are hopefully choosing a long-term partner that will help you to grow your US-based business.
EAS Consulting Group, a Certified Group company, can help with your next import. View our website to see our US agent services or send us your questions.