Understanding FDA Registrations and the Role of Your US Agent
Presented by Victoria Pankovich
Does your facility need to register with FDA, and if so, when is a U.S. Agent required?
FDA registration requirements vary depending on the products a facility manufactures and the activities it performs. For foreign facilities subject to registration requirements, appointing a U.S. Agent may be an essential step before doing business and importing products into the United States.
In this complimentary webinar, EAS Consulting Group will examine FDA facility registration requirements and the role of the U.S. Agent across foods, dietary supplements, cosmetics, drugs and medical devices. The discussion will also explore how a regulatory U.S. Agent can support communications with FDA, establishment inspections, submissions and other regulatory activities.
What You’ll Learn
- When FDA facility registration is required and when a U.S. Agent must be appointed
- The U.S. Agent’s role as an intermediary between foreign facilities and FDA
- U.S. Agent responsibilities related to registrations, product listings and FDA communications
- Additional situations requiring a U.S. Agent, including certain drug and medical device applications and color-related submissions
- How regulatory U.S. Agents can provide support beyond registration, including application reviews, inspection preparation, corrective action plans and regulatory questions
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About the Presenter
Victoria Pankovich
Manager, Regulatory Services
Victoria serves as the US Agent contact for all required communications with FDA on behalf of EAS clients, including Establishment Inspection coordination with FDA. This includes Drug, Medical Device, Food, and Cosmetic facility registrations; Drug, Medical Device, and Cosmetic product listings; Batch Color Certification requests; FDA Inspection Notifications; FOI and FDA Controlled Correspondence requests. Support also includes communication with the agency for submissions of Drug Master Files, Abbreviated New Drug Applications and New Drug Applications.
Do I need to register my facility with the FDA?
This depends on the FDA division that regulates your products and your business processes.
Why Do I Need an FDA US Agent?
Foreign companies planning to manufacture/process and export Drug Products, Medical Devices, Foods, Dietary Supplements, Cosmetics, and the color additives used in Food, Drugs and Cosmetics to be sold in the US are required to enlist the services of a US agent by regulation.
What are the Basic Requirements to be an FDA US Agent?
FDA US agents must have a physical address (not a post office box) in the United States. This cannot be in the form of an answering service. The US Agent must be physically located at this address and be available during business hours, with a contact phone number and email address.
Posted in Dietary Supplements, Drugs, Foods, Medical Devices, On Demand Webinar.