What does FDA approval actually mean?

At Altaflo, many of our products are approved for applications in compliance with FDA regulations.

But what does that actually mean? We take a look at who the FDA is, what their screening process entails, and why their stamp of approval is so important.

Who is the FDA?

The U.S. Food and Drug Administration (FDA) is a body that examines, tests, and approves a range of items for medical and food industry use. Some of the items that the FDA evaluates include new drugs, food additives, medical devices, and materials used in food contact applications.

What do they do?

When evaluating materials, ingredients, and devices, the FDA makes use of a three-tier screening process, which divides items into high risk, moderate risk, and low risk categories. In order for an item to be approved by the FDA, it has to be proven that it is safe and effective for use. Essentially, the benefits of using the item must outweigh any potential risks.

Which Altaflo products are FDA approved?

A wide range of our products are FDA approved. Our Altafluor 100 PTFE tubing, which is the most flexible of all fluoropolymer tubing available, is FDA compliant and can be safely used in food contact applications. Additionally, our Altafluor 200 FEP tubing; Altafluor 400 PFA tubing; Altafluor 450 UHP PFA (high purity perfluoro alkoxy); Altafluor 480 UHP PFA (ultra-high purity perfluoro alkoxy); Altafluor 500 PVDF (polyvinylidene fluoride); and Altafluor 550 PVDF Flex tubing are all FDA compliant for food contact.

If you have a question about any of our products, please don’t hesitate to get in touch.

If you would like to make an order, please take a look at our ordering information here. If you are not yet sure which Altaflo product best suits your specific needs, we recommend that you read our material selection chart.

Do you have a question?

We are dedicated to providing you with the highest quality products and services

  • Phone 973 300 3344
  • Fax 973 300 3345
  • Email sales@altaflo.com
  • Address 23 Wilson Drive
    Sparta NJ 07871