FDA Cleared vs. Medical Grade Materials vs. FDA Approved

Mar 16, 2018

When browsing Amazon, eBay, or other online retailers, you will frequently see the claim that a cup was made with medical-grade silicone.

Unsurprisingly, we frequently receive the question, "Is the MeLuna USA period cup made with medical-grade material?"

Today, I would like to take some time to discuss how much (or little) value there is in the medical-grade material claims of some manufacturers and how much is involved in getting a cup FDA-cleared. By the way, the correct term is cleared or registered, not FDA 'approved' when it comes to menstrual cups. If you see this term in a cup advertising, it should immediately raise a red flag.

First things first, though: ALL components of the MeLuna USA menstrual cups are medical-grade materials. In fact, the materials, including the colorants, were registered with the FDA and used in other medical device applications long before we started applying for FDA clearance and producing MeLuna USA cups made with these components.

So why emphasize medical-grade materials in online ads for cheap, unregistered cups?

It's easy to use the term to advertise and put consumers at ease about a product that is NOT FDA cleared or registered. It may contain other components that are not medical grade and be manufactured in conditions not meeting medical device manufacturing standards. This is misleading and taking advantage of consumers.

Think of it this way: I could make you a pie and use organic apples. I could claim the organic apples when I advertise for my pies. But you still would have no idea what other ingredients are in the pie or if the pie was made in a clean kitchen, etc. Medical-grade silicone is just one component of a cup and does not indicate the quality or safety of the finished product.

FDA clearance goes much beyond medical-grade materials. It also means the cup is manufactured in an FDA-registered facility and imported by an FDA-registered facility. The FDA inspects FDA-registered facilities regularly to ensure good manufacturing practices are being observed and quality control systems are in place.
The US distribution facility in Texas and the state-of-the-art manufacturing facility in Germany have been thoroughly inspected by the FDA. An FDA agent is on-site for four days to observe during each inspection.

Do you have to trust us on this?

No! The FDA database is accessible to the public for searches.

For example, here are the search results for MeLuna menstrual cups:

510k Clearance for MeLuna USA Menstrual Cups
The 510(k) clearance process involves a comprehensive review by the FDA of the device's safety and performance data, which may include scientific, non-clinical, and clinical data. Please note that as of 2015, this is no longer required, and there may be FDA-registered menstrual cups that did not complete the 510 (k) clearance process. MeLuna has completed the 510k process and has obtained clearance demonstrating the highest level of safety for menstrual cups.

Establishment Registration and Device Listing for MeLuna Menstrual Cups

Ready to check on the FDA Registration of a cup you own?

Search the FDA Database

There is no oversight over factories in Asia or elsewhere that distribute cups that are not FDA-registered and bear only the medical-grade silicone claim.

We strongly suggest you do not fall for these claims and instead choose a cup with a proven safety standard. Maybe MeLuna is not the cup that appeals to you the most? There are many quality cups out there with FDA clearance to choose from. If you don't choose MeLuna, please consider selecting another cup of equal quality. If in doubt, you can search for menstrual cups on the FDA website to see if a cup brand you are interested in is FDA-registered.*

Remember, if you ever see the term 'FDA Approved' on a Menstrual Cup, it should raise a red flag. The FDA does not approve menstrual cups. A menstrual cup, after having gone through the lengthy clearance process, is considered FDA cleared. At this time, this process is no longer a requirement, but it does show what high standards the device has met if it does have a 510k clearance. Menstrual products like pads, underwear, and cups still have to be FDA registered, though, and are subject to inspections.

Yes, that's right! Even menstrual pads and underwear must meet this requirement. While menstrual cups are worn internally and therefore fall under Medical Device Class II, Pads are included in Class I devices.
Erroneously, some online sources say period underwear is not regulated; however, it falls within the cloth pad category and would be registered as such.

Here, for example, is the FDA Device Registration for Domino Pads Cloth Pads.

You have many choices when it comes to reusable menstrual products. If you choose a MeLuna USA menstrual cup, THANK YOU SO MUCH! We put a lot of work into bringing these cups to you and take pride in providing you with an outstanding, quality, safe product!

Karin

CEO MeLuna USA

*If you live in a different country, your country may have their own health agency that you can check

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