About US FDA
The United States Food and Drug Administration (US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, food, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect public health and reduce tobacco use by minors.
What is FDA Registration?
FDA registration is the process whereby a domestic or foreign facility registers with the FDA as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations. The FD&C Act requires that manufacturers, re-packers, labelers, and private labelers of human food, animal feed, pharmaceuticals, and cosmetics that are marketed in the United States register with the FDA. In addition, manufacturers of medical devices intended for human use that are required to register must list their products with the FDA.
What Products Are Required to Be Registered with the FDA?
The following products are required to have FDA registration to be marketed in the United States:
Benefits of US FDA Registration
There are many benefits that come with US FDA Registration:
- Ability to conduct business in the United States
- Ensures your products are safe and compliant
- Demonstrates a commitment to quality
- Increases customer confidence
- Fulfills legal requirements
- Gain a competitive advantage
How IAS Helps with FDA Registration
Integrated Assessment Services has extensive experience in helping companies obtain FDA registration. We have a network of agents and affiliates around the world that can help you with the FDA registration process — including US Agent services — no matter where your company is located.
Contact us today, or email enquiry@iascertification.com, to learn more about how we can help you obtain FDA registration for your product.
The FDA Registration Process
Submit Application
Submit an application to IAS.
Product Analysis
Analysis of your product(s) by our technical experts.
Product Testing
Sending the product(s) for appropriate testing, where applicable.
US FDA Agent
Appointment of your US FDA Agent.
Registration Completed
Your facility and products are registered with the FDA, and you receive your FDA registration confirmation.
Annual Renewal
Ongoing annual renewal services to keep your registration current.
