US FDA Agent / US Agent
US FDA Agent acts as a primary point of contact between the facility and the FDA in case of any emergency and routine registration matters. We are one of the most reputed US FDA agents to assist food, drugs, medical devices, nutraceutical and cosmetic manufacturers and exporters across the Globe.
All types of food, drug, cosmetic and medical device manufacturers must hire a US FDA Agent if they are from a foreign land
Type of Industries US FDA Agent Mandatory
US FDA Agent is mandatory for the following types of facilities that wish to export to the USA.
- Drug manufacturers
- Medical Device Manufacturers & Exporters
- Food Manufacturers and re-packers
- Nutraceutical manufacturers
- API manufacturers
- Cosmetic manufacturers
- Testing Laboratories
- Sterilization Facilities etc.
Responsibilities of US Agent
Following are the responsibilities of an US FDA Agent
- Gets the latest updates from the FDA.
- Facility Registration and maintenance of account Info.
- Coordinates with the FDA for any communication.
- Label review service ( Additional Service Fees applicable)
- GMP guidance ( Additional Service Fees applicable)
- Assists the FDA with scheduling foreign facility inspections.
- Performs an annual registration update.
- Importer information update (Drugs & Medical Devices)
- Additional Listing any time in the service year.
- Performs initial registration and listing
- DUNS number and Address verification
- FEI number request
- Protects each firm’s login information.
- Issue of Registration Certificate.
How to select a US FDA Agent?
Foreign manufacturers and exporters must carefully evaluate the credentials of the US FDA Agent before appointing them as your company representative. The following are important points to remember:
- Must be a lawfully registered firm in the USA
- Must have the necessary experience and knowledge in Drugs, Food, Medical devices & Cosmetics regulation
- Must NOT be a single individual operating from his/her home or workplace
- Must be a company dedicated full-time to regulatory compliance
- Must be aware of FDA Regulatory updates and should communicate to the customers
- Should be neutral and should not have any link with US importers or dealers.
Working with FDA 510k consultants like I3CGLOBAL helps manufacturers prepare and respond to FDA queries more efficiently and effectively, ultimately speeding up the 510k approval process and bringing their medical devices to market faster.
Frequently Asked Questions
Is US FDA Agent mandatory for Food, Drug, Medical Device & Cosmetics Importers?
All foreign establishments importing and distributing food, medical devices, and drugs need to appoint US FDA Agents. Cosmetics US Agent is not mandatory. A domestic manufacturer’s US Agent is not required.
What is the process of US Agent appointment?
Fill out the online application form and make the annual fees.
Is US FDA Agent responsible for vigilance Control?
Not applicable to Food manufacturers. It applies only to Drugs and medical devices. Vigilance and post-market surveillance separate agreements to be made with US Agents with additional fees.
Is US Agent appointed by FDA?
US Agent is Independent. Not approved or recognized by FDA authorities.
Is the US Agent issued Certificate is valid? Is it authorized by FDA?
FDA Agent Certificate is not authorized by the FDA.
Why US FDA Agent charges fees annual even FDA food registration is biannual?
FDA Agent agreement is normally made for one year. Customers have the choice to make for multiple years.