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.'”
“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.