The Role of Your US Agent
This webinar covers what a US agent must do per FDA regulations as well as identify opportunities for enhanced services should the agent have relevant experience and expertise. You’ll learn important considerations that will enable you to choose an FDA US agent that best fits your needs and business.
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Why Do I Need an FDA US Agent?
FDA requires foreign companies to enlist an FDA US agent for certain establishments and activities in some of its regulated segments prior to selling products in the US. Companies planning to import Drug Products, Medical Devices, Foods, Dietary Supplements and Colors Certifications for color additives used in Food, Drugs and Cosmetics sold in the US are required to enlist the services of an agent.
What the Basic Requirements to be an FDA US Agent?
FDA US agents must be US-based, with a physical mailing address (not a post office box), telephone number that is answered in person during business hours, fax number and email address. The agent must be able to accommodate time zone differences and language barriers to help the foreign entity communicate with FDA.
What Does an FDA US Agent Do?
The main purpose of an FDA US agent is to liaise with the FDA on behalf of the foreign entity they represent. This includes:
- Written and oral communications with the FDA
- Facilitation of formal submissions
- Communication of requests and notifications
It is important to note that an agent can NOT make decisions on behalf of a foreign firm – they will only act as a communication link.
Additionally, in the event of a drug recall, FDA must be notified of the recall by the agent (a practice that is also recommended for all other regulated products).
What Should I look for in an FDA US Agent?
A good partnership with your FDA US agent is essential to ensuring your company’s objectives are met. When choosing an agent, look for one with the following qualities:
- Strong background and regulatory expertise in the field/product segment in which your company is engaged
- Responsiveness in communication and ability to provide adequate coverage to facilitate communication between your company and FDA
- At least a base level of understanding of FDA’s internal operations, processes and approach
- Ability to conduct registration, product listings and updates
Importing products into the US is challenging, and each product area has its own set of complications. Your FDA US agent should be able to help you to navigate those. For instance, understanding the Top Challenges for US Bound Food Imports is an important first step for importers of food into the US. Choose an agent that can best support all your business needs.
What are Other Areas in Which an FDA US Agent Can Provide Assistance?
Depending on your FDA-regulated business and the expertise of your FDA US agent, there are many additional services you may be interested in your agent providing. Commodity-specific examples include the following:
Pharma: Preparation and filing of IND, NDA, ANDA and DMFs
Medical Devices: Preparation and submission of 510 (k), 513 (g), PMA, IDEs
Food Facilities: LACF registration (required in addition to Food Facility Registration)
Color Manufacturers: Submissions for batch certifications of color additives
Again, ensure prior to enlisting any additional help from an agent that they have demonstrable expertise that enables them to provide appropriate guidance and support.
How Else Can FDA US Agents Help?
GMP Inspection Preparation
Regardless of the FDA product type, FDA US agents with expertise and experience can be invaluable in helping firms prepare for an upcoming FDA facility Good Manufacturing Practices (GMP) inspection. Generally, agents are the first to receive notice of an upcoming inspection. With appropriate experience, agents can provide an overview of how FDA conducts foreign GMP inspections and what to expect.
Responses to FDA 483s and Warning Letters
While not required, an FDA US agent with relevant experience may be able to advise on regulatory guidance for FDA 483s and Warning Letters and what type of cGMP corrections the FDA is looking for. Agents may also be able to submit FDA 483 and Warning Letter responses to the FDA on your company’s behalf. Having an understanding of FDA’s processes, regulatory and administrative requirements can help improve the outcome of your filing. Your agent may also be available for follow-up with FDA reviewers.
Assistance with Product Withdrawals or Recalls
When faced with a product withdrawal or recall, FDA expects foreign facilities to communicate the details via their agent. Once the initial notice has been made to the FDA by the agent, follow up will be directly with the foreign firm. This communication needs to happen up front and presumably before any recall actions are taken.