FDA Registration



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 is required to register must list their products with the FDA.

What Products are Required to be Registered with 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. They are as follows:

  • 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 comp competitive advantage

How to Obtain FDA Registration through IAS?

Integrated Assessment Services is a global certification body with 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, no matter where your company is located.

The following steps are involved in obtaining FDA registration through IAS:

  • Submit an application to IAS
  • Analysis of your product(s) by our technical experts
  • Sending the product(s) for appropriate testing
  • US FDA Agent appointment
  • Registration approval
  • Annual renewal services

Contact IAS today to learn more about how we can help you obtain FDA registration for your product.

E-mail: enquiry@iascertification.com