CFR Tags on Used CT Scanners: What Are They & Why Are They Important?

When we are offered used CT scanners from countries outside the USA, we always ask "Do you have pictures of the tags that include the FDA’s 21 CFR language?” Many times, our client or supplier is unfamiliar with this terminology and asks us many clarifying questions. So we thought it would be wise to explain in greater detail via a blog post! So here goes…

Common Questions About CFR Tags

What is a CFR tag anyway?

CFR stands for Code of Federal Regulations and the CFR tag verifies that the CT scanner is FDA approved for use in the U.S. These tags will clearly state something to the effect…

“This product complies with DHHS rules, 21 CFR Subchapter J, Applicable to the Date of Manufacture.”

And even though this blog post is addressing CFR tags on CT Scanners specifically, these very important regulations apply to ALL radiological “light-emitting products” being installed in the U.S.

What does a CFR tag look like?

If the intent is to bring the equipment into the U.S., the CFR tag must be in English.  Some equipment may have the CFR tag but in a different language for marketing purposes. The unit probably meets the FDA regulations but was not actually FDA certified. We learned this very valuable lesson the hard way after purchasing a C-arm from Europe that had a CFR tag in German… the FDA would not allow importation into the U.S.!

Where is the CFR tag located?

You will find these tags usually located on the back side of the gantry, at the bottom near the manufacturer’s tags.

Why are CFR tags so important?

In our ever growing need for due diligence, we have discovered that not all medical imaging equipment has been approved to come into the U.S. It used to be the common thought that all equipment was "O.K." for the USA. But as many have found out, this is certainly not the case.

A common phrase around our office is "Everyone is responsible for due diligence." If we do not take the necessary precautions, we run the risk of exposing patients and technicians to potentially dangerous amounts of radiation or improper scanning and our company serious fines.

This is why we must be meticulous in making sure that equipment offered from other countries meets FDA standards.

If you want to be certain the scanner you plan to import to the U.S. is fully compliant, make it a priority to speak with your Block Imaging representative so we can help you with that important decision. And if you are ready to sell your scanner, submit imaging equipment specification here to request a quote.

Let's all take responsibility for FDA compliance and patient safety!

Picture of Trish Payne

Trish Payne

Trish Payne is Block Imaging’s OEM and FDA Liaison. Trish is passionate about understanding the causes of challenges and working collaboratively to overcome them for the good of the imaging industry and the healthcare providers it serves. In addition to keeping Block Imaging’s work in step with industry standards, Trish is a wife, mother of two, tennis player, and world traveler.