This past week we completed our first FDA Inspection here at MeLuna USA headquarters in Texas.
One of our lovely retailers, Ova Woman, brought up an interesting topic: Why just why would there even be an inspection since menstrual cups are now 510(k) exempt?
We thought this would be a great topic to write about on our new blog. Here's what's happening in regards to menstrual cups and the FDA:
Just a couple of years ago the regulatory status of menstrual cups was pretty clear:
New cups had to be cleared by the FDA in a process called 510(k) Premarket Notification.
Last year this requirement was removed and menstrual cups are now exempt from the 510(k) process.
Our MeLuna cups were cleared prior to this change which means our cups have a 510(k) number and have cleared the premarket notification process.
What confuses even many manufacturers is how to interpret this.
To better understand this, let's look at a chart of the FDA clearance process. This chart below belongs to a consulting group called Emergo. We are not affiliated with them and have not used them but they definitely deserve credit for creating this awesome chart!
Menstrual cups are considered a Class 2 Medical device. That has not changed. All of the items you see in yellow apply to Class 2 Medical Devices.
The very first item you see is about implementing a Quality Control System compliant with a certain section of regulation (CFR Part 820). This is super important and this is the system manufacturers are audited on later.
Now let's look at the chart again to see which parts are actually exempt now:
As you can see it's just the area in the middle that is exempt... the 90 day review process.
Compliance with CFR Part 820 is still of extreme importance and the FDA still performs audits on Medical Class 2 device facilities, even if the device is exempt from the 90 day review process.
Now here comes the part many manufacturers tend to overlook:
An important part of the quality control system is something called 'Design Controls'.
Design Controls include all of the specifications of the device. Design Controls still have to include all of the FDA required testing.
It is just the 90 day review process the cups are now exempt from. For a Class 2 device all of the design controls including testing are still required.
In fact we currently are working on completing testing requirements on a lovely new color!
Menstrual cup manufacturers and importers are still being audited because compliance with the standards in CFR Part 820 are still a requirement even though the 90 day review process is no longer in place.
Most importantly you -the consumer- still benefits from the safety a cup made to FDA standards provides.
We hope those interested in this subject found this post helpful. Let us know what you think in the comments!