I have not been asked to write or compensated for this post. It is entirely my opinion. I am not a lawyer.
Yesterday, it came to my attention that a WAHM cloth menstrual pad manufacturer was just notified that their products were now classified as class I medical devices & they would have to pay to register with the FDA.
Update: The WAHM in this instance has decided to pursue a business loan to cover the fees.
Understandably, women were outraged. In the cloth diaper community we tend to be very protective of our WAHMs and angry when they are treated by government agencies as equals to big business. Many WAHMs start sewing for themselves, then friends & family, then selling to others, then grow over time. They don’t necessarily start out with a large investment and meet with attorneys before they begin.
I was really surprised that this happened so suddenly with no notice, so I’ve spent the past two days doing some research. I’ll admit that I hadn’t done any such research before now, because I had no reason to. Please note: Lunapads (a Canadian company) has been registered with the FDA since at least 2008 when this blog post was written. In fact, after contacting them I found out that they have been compliant since 2001. I found that blog post when searching for more information about the FDA’s classification & regulation of reusable menstrual pads.
Under the Medical Device User Fee and Modernization Act (MDUFA), manufacturers and importers of medical devices are subject to Medical Device Registration & Listing to track where medical devices are imported or manufactured, as well as pay an annual registration fee.
The schedule of annual registration user fees for fiscal years 2013 through 2017 follows:
Year FY 2013 FY 2014 FY 2015 FY 2016 FY 2017
Fee $2,575 $3,313 $3,646 $3,872* $3,872*
* These fees are estimates. Actual fees for that fiscal year will be determined and posted by August prior to that fiscal year.
Page 20 of this document from The National Conference of State Legislatures, written by Erin D. Williams and entitled Medical Device User Fees and User Fee Acts has the following information on use of fees collected:
“One provision[…]states that fees ‘shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of device applications.'”
Also:
“The law specifies that fees are to be used to support FDA in achieving the performance goals identified in the Commitment Letter.”
Click the link for complete information.
Reusable menstrual pads have been Class I Medical Devices since at least 1996 according to my research. In 2002, Congress first granted FDA the authority to collect user fees from medical device establishments. In 2007 the FDA was reauthorized to collect such fees. The authorization was renewed in 2012.
This brand has been around since 2007, and I suspect that they simply had no idea. Unless they sought out the info, they wouldn’t have known. I’m glad the FDA isn’t going after them for 7 years of registration fees, and I hope they are able to change their business model to cover future fees. I just bought this brand mama cloth (edit: A.K.A. reusable menstrual pads, commonly called “mama cloth” in the cloth diaper world, this term isn’t intended to offend or exclude anyone. I am aware that even people who don’t identify as female can and do menstruate.) myself about a month ago and am looking forward to trying it.
I have a good bit of experience reading “legalese” from dealing with Maryland’s Code of Regulations, and my professional experience with insurance regulation, but it still took me a good deal of time to read and begin to understand all the “ifs, ands, buts” etc. of these regulations.
The FDA has a small business assistance document covering Medical Device Establishment Registration & Listing. This indicates that along with the requirement for electronic registration in 2007, fees for some establishment types were implemented. In 2012, fees for all establishments were implemented, adding fees to contract manufacturers and sterilization facilities among others. Considering the Lunapads blog post in 2008 where they specifically stated that they paid registration fees to the US FDA, I suspect cloth pads were not added in 2012. Before you call me a small business hater, Lunapads had 5 employees at the time of that blog post.
Fortunately, cloth menstrual pads are class I medical devices and aren’t subject to the same regulations as other medical devices, such as premarket approvals applications (PMAs), product development protocils (PDPs), premarket reports (PMRs) & more that cost tens of thousand of dollars, even for small businesses. While I certainly don’t want to discourage any new WAHMs, I highly suggest a business plan and extensive research, including meetings with an attorney, before getting started. I suspect that they simply came on the FDA’s radar for some reason. I’d be very interested to see the actual letter they received and read the wording. I was notified that they did not receive a letter or get singled out in any way by the FDA. They simply found out it was required and of course, will comply.
One more addition: Domino Pads is registered and compliant. Glad Rags are as well. I of course don’t know what their sales volumes or profit margins are like, but their pads are very reasonably priced and quite popular.
If a brand sold 20 pads per week and currently sells their pads for $10, they could add about $3.50 to the price of each pad to cover the registration fee, and still be very competitively priced. At 50 sold per week adding less than $1.50 to the price would cover the fee.
Please also read: Lunapads post on FDA compliance and the cost of doing business.
Side note: I also learned about interlabial pads today. I had no idea they were a thing. I thought they were saying that menstrual pads were held in place by the labia, not underwear!
There is a petition to lower or reduce registration fees for reusable menstrual product makers if you’d like to sign.
Maria wants to live in a world where cloth diapers are the norm and moms can make parenting choices without judgement. When she’s not chasing her 18, 14 and 11-year old kids around, you might find her checking out the latest gadgets, organizing something (again) or exercising in the fresh air. 
[…] has been a recent flurry of activity on the topic of FDA registration and questions from our customers about whether Lunapads are FDA compliant. The short answer is YES […]
I think the bigger problem is that menstruation is considered a medical condition that requires a medical device!
I do kind of get that things worn internally, like a pessary, menstrual cup or tampons need additional regulation to ensure safety. Cloth pads though? I suppose I don’t see how they are much different than underwear with additional absorbency. They’re not loaded with chemicals, bleached etc.
I was thinking the same thing but disposable pads are classified that way too and they can be loaded with chemicals, bleached etc. I doubt the big disposable companies would like it if reusable versions weren’t regulated and I prefer that those big companies have some review of their products! Seems kind of stupid since cloth has been used for centuries but regulation is the name of game now.
I think disposable pads need a thorough review. They are directly next to delicate skin 24 hours a day, 5 days a month for years & years and contain…?…no one really knows!
So true! I used some recently that felt like they were made of blue memory foam?!?!
I bet she knew and chose to take the risk. This is not a new thing. I don’t have a shop but know about it. Btw you may want get permission to reference her here… she had another blogger edit his story. Furthermore, please if you would consider using more inclusive language in the future… teen girls and non moms use cloth pads… not mama cloth! I despise that wording… last thing? The change affects all cloth pad makers. I don’t feel like pls was directly under attack from the fda, who more than likely found out the same as everyone else did about the change and updated her page as such. For professionalism sake, it may be good not to make assumptions in a public blog… And get permission from the people you mention.
The problem was someone wrote them asking for clarification, and then they decided to include the items. Basically they asked the FDA to regulate us, until then cloth had flown under the radar. You can thank the people who wrote the FDA for that mess. Sometimes its better let sleeping dogs lie!
That’s not true. The FDA went into a review period to see if they can exempt most class 1 devices from premarket notification and cloth pads happen to be class 1 devices so they became exempt from premarket notification. Now it is cheaper to become complaint. Nothing else has changed.
your right! I did further research and realized my mistake. I got caught up in the drama last night!
Haha, it took me a stupidly long time to figure out what I was looking at with that interlabial pad! 😉 What a fun new thing to learn about, though. I hadn’t heard of those before.
I know, yikes! Doesn’t seem comfortable at all but to each her own I guess!
Interesting. When I was a teen with heavier flow it would have been nice to avoid the “channeling” at bed time.
It seems odd that pads are considered a medical device and subject to these fees. Are diapers in this same category?
Cloth diapers are children’s apparel and regulated by the CPSC and subject to CPSIA testing & labeling.
Silly question, why wouldn’t mama cloth be considered apparel just as cloth diapers are?
Not according to the FDA. I assume because they go beyond just being worn on the body and go to intentionally collecting menstrual fluid.
Cloth pads are considered a medical device to “treat” the medical condition of “menstruation” lol
So PLS, who has amazing products by the way, is being taxed/fined $3700 per year?!?! And are they now covered by my insurance? So they are paying to give away their own product basically. What a scam. Let’s hope she can raise the funds quickly. And let us hope that don’t do the same to our cloth diapers (or do they already?)
They have always been subject to an annual registration fee as a manufacturer of a class 1 medical device, they only recently realized this.
These regulations have ALWAYS been in place. A TON of Class 1 medical devices were just reviewed and had premarket notification removed from being a requirement so now it’s CHEAPER to become complaint than it was before.
Right!