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FDA Registration vs FDA Approval: What it Means for Your Menstrual Cup

Breaking Down Exactly What an FDA Approved Menstrual Cup Is 

The term FDA is thrown around a lot when it comes to most of the things we use in our daily lives—even when it comes to menstrual cups. 

From the food we eat to the medical devices we use, the FDA plays a big role in monitoring what’s safe and healthy for us to use and consume. But did you know that there are different tiers of FDA endorsements? 

It’s true. Which begs some questions—where do menstrual cups fall? Are they FDA-approved? 

In this article, we’re going to dive into how the FDA classifies menstrual cups and explain the difference between FDA registration and FDA approval. 

What Exactly is the FDA? 

The FDA is a United States federal agency that’s a big part of the Department of Health and Human Services. 

Part of their job is to ensure the public has access to accurate, science-based information that’s necessary for making healthy decisions about medical products, food, and more. 

There’s a long list available (right here, actually) that spells out exactly what the FDA regulates, but we’ll go ahead and give you at least one spoiler—they also regulate menstrual cups.

Because menstrual cups are nationally recognized as medical devices—and because all medical devices in the U.S. are supposed to be regulated to some degree by the FDA—it should come as no surprise that cup companies—JUNE  and every other brand—are required to involve the FDA in their process. 

FDA Registration vs FDA Approval: Understanding the Difference 

Because menstrual cups are considered medical devices, by law, the FDA has to be aware of them.

But this is where things get kind of interesting—and sometimes a little confusing, too. 

While all medical devices need to be brought to the FDA’s attention, menstrual cups do not have to undergo the same approval as other devices. Menstrual Cups fall into  class II (out of three medical device classes), and cannot be FDA approved, only FDA registered.

But wait a sec—what’s the difference here? And most importantly, does that difference matter? 

Let’s break it down by definition to really make this as clear as possible. 

Medical devices are placed into three categories in the United States—class I (considered lowest risk), class II (considered medium risk, like your menstrual cup), and class III (what the government considers high risk—like, pacemakers and similar devices).

Whichever classification a medical device falls into determines the specific label that goes hand-in-hand with that device. In other words, the FDA uses these three classes as a recognition tool for the level of control that’s necessary to assure that people can use them safely, correctly, effectively. 

So, What is FDA Approval?

FDA Approval is the required label that goes hand-in-hand with class III medical devices. It’s also sometimes referred to as FDA cleared. To make this clearer, only class III devices can be approved by the FDA. 

It’s important to realize that the term “FDA Approved” is reserved for class III devices. Typically, class III devices will sustain or support life—they’re implanted or present unreasonable risk of illness or injury. 

If class II devices—like menstrual cups—claim to be FDA approved, the FDA has a problem with that, stating “any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.

What is FDA Registration? 

FDA Registration, on the other hand, is reserved for class I and class II devices. That means that every medical device in these classes must be registered with the FDA and must prove to the FDA that it’s “substantially equivalent” to another product that the FDA has already granted clearance to. 

Menstrual cups are considered to be class II medical devices, which means they’re not FDA approved, but rather, FDA registered—meaning that the FDA needs to be aware of and register the specific product (the cup) and the establishment (the company that makes the cup). 

Is the June Cup FDA Registered? 

Yes – the June Cup is proudly registered with the FDA.

You can find our registration info below:

FDA Registered Owner Operator Number: 10079962

Medical Device Registration Number:  D361158

All menstrual cups that are produced and distributed in the United States—even the ones that are imported from China or other countries—have to be registered with the FDA.

Picking the Perfect Menstrual Cup: Due Diligence is Your Best Friend 

Ultimately, picking the perfect menstrual cup is going to be totally up to you—but a dash of due diligence can go a long way.

Knowing the difference between FDA-approved and registered can be super helpful for you—so can knowing which cup is the right fit. Check out our JUNE Cup Quiz right here for a little insight on how to choose the perfect-for-you June Cup fit! 

Have some cup Qs? We’ve got you! Reach out to the JUNE team right here at hello@thejunecup.com for more help! We’re glad to help out however we can.

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