Articles

Roles and Responsibilities of FDA US agents

by John Smith Digital Marketing Expert
Foreign companies who import or act as a catalyst in importing into the United States identify as FDA U.S. Agents while registering. The FDA U.S. Agents must be located somewhere in the US from where the contact between the FDA and the firm becomes reliable.

The Role of the FDA U.S. Agent is as follows:

  • The basic role of FDA US AGENT is to Review, disseminate routing, and respond to all communications from the companies and the consumers.
  • Its role is to respond to questions concerning the drugs that are imported to the United States.
  • To schedule regular inspections on the drugs.
  • If the FDA cannot contact any foreign registrant directly or indirectly, the FDA will provide the information and documents to the United States agent. 
  • The packaging and labeling provide all information and documents the same as the information presented to the foreign registrant.
  • Appointing a US Agent is an essential requirement for foreign companies selling drugs or medicines, other medical equipment, food, and dietary supplements.

The Responsibilities of US Agent:

The main responsibility of an FDA US agent is to communicate between the FDA and the foreign company.
The Agent chosen by the FDA should understand the compliance issues, product-related problems, or inspection schedules.
FDA agents 
play an important role in FDA regulatory matters. 

Who is responsible for the appointment of a FDA US Agent? 

  • Foreign 
  • Food, drug, and medical devices are authorized to register under FDA.
  • Companies are required to submit the controlled correspondence to the FDA.
  • The FDA requires all medical devices and IVD companies are intended to get registered. The Agent must be a resident of the United States or be in any way in touch with the US.

Why should US FDA Agent Services be chosen?

FDA US Agents service should be chosen because:

  • Established experienced
  • Lowest fees
  • No hidden charges
  • All services under one roof
  • Food facility registration and Medical Device registration and listing are exempted from any fees.
  • No extra fees are needed for the shipment of medical equipment.
  • All services are expected to be under one roof.
  • Keeping in mind the Strict clientele confidentiality.

eCTD and 356(h):

Foreign companies should designate their FDA U.S. Agent as part of the eCTD submission by providing an appointment letter of Section 1.3.1.2. which is used separately. The newly appointed FDA US Agent is expected to sign Form no.356 too. The Signature of Applicant’s Responsible or other Authorized Official and section 37 is highly recommended by the FDA U.S. Agent.

Conclusion:

FDA US Agents are one important part of the US regulatory board. Without its interference, one cannot import drugs to the US. The participation of the agents is highly recommended and needed knowing its capacity to handle issues regarding the health and life of the consumers.

Sponsor Ads


About John Smith Senior   Digital Marketing Expert

343 connections, 3 recommendations, 970 honor points.
Joined APSense since, June 14th, 2012, From Delhi, India.

Created on Sep 9th 2021 02:49. Viewed 233 times.

Comments

No comment, be the first to comment.
Please sign in before you comment.