There were a lot of major takeaways from the COVID-19 pandemic, but a surge of interest in the Food and Drug Administration (FDA) and why its standards matter was at the top of that list for millions of Americans desperately looking for safe and effective answers. Many people learned about how stringent FDA regulations are for the first time during this collective limbo, and it shed new light on the important oversight the agency provides for keeping us healthy.
In addition to determining food and product safety, the FDA has the authority to regulate over-the-counter fertility drugs and at-home treatments. The FDA requires clearance for Class II medical devices related to conception and fertility, including popular products like intravaginal insemination (IVI) kits.
As great as it is to see growth in this industry, there are still many at-home fertility treatments that aren’t currently regulated by the FDA, which opens the door to a wide range of quality-control issues. That may not mean much in some markets, but infertility is as personal and meaningful as it gets, and we want to make sure you have the necessary knowledge to make the best decisions for your own journey.
If you’re struggling with infertility, the last thing you need is more questions. Here are all the answers you’re looking for about fertility treatments and what those FDA labels mean.
The Importance of FDA Clearance
The FDA is America’s national rule maker and regulatory organization for drugs, foods, and medical products. They underwrite public health and safety by analyzing extensive testing data, and when they put an FDA-cleared stamp on a product, it means consumers can trust that it’s safe for them to use as intended.
For a long time, things like IVI kits were off the radar of the FDA, and that meant a market flooded with a host of unsanitary and unsafe products. As scary as that sounds—and it was—new regulations have thankfully made it a requirement for all IVI kits (and many other fertility treatments) to receive FDA clearance.
It’s been a huge blessing for people struggling with fertility issues in America. FDA regulation of over-the-counter reproductive devices has dramatically upped the bar for the health, safety, and dignity of the people using them to ensure they have options worthy of the life they’re creating.
A Quick Note on “FDA-Approved” vs. “FDA-Cleared”
Just so we’re clear, you’ll see both of these terms used, and they mean very different things. Here’s the difference:
FDA-approved (or Class III) products are reserved for the most high-risk drugs and medical devices that are only offered in a clinical setting. This category includes things like cancer treatments, heart valves, and other devices that pose the highest risk to consumers. These products are the most rigorously tested to ensure their benefits substantially outweigh the risks.
FDA-cleared (or Class II) products are reserved for medical devices and tests that are only in the body for a short time and can be prescription or over-the-counter. When compared to implanted devices, they’re less risky to consumers. However, they must still be safe because they pose more risk than something like a Band-Aid which is considered a low-risk device. Pregnancy tests, tampons, condoms, and now insemination kits all need to be FDA-cleared to prove they are safe for consumers to use.
PherDal is proud to have undergone more clinical testing than any other insemination kit in history. Not only did we clinically validate our methods in the largest cohort of users, but we also proved our IVF-grade materials were safe for both sperm and vaginas, while being the only sterilized kit on the market, to protect against microbiome disruptions that can cause infertility.
At-Home Fertility Testing
Personal-use fertility tests help people understand their fertility window without ever going to a doctor’s office. They’re an excellent component of at-home fertility health and support valuable conception aids like IVI kits.
These products might involve sending a blood sample in the mail to a CLIA-certified lab or the use of an app. However, even apps are required to be FDA-cleared if they qualify as “software as a medical device.”
The best fertility tracking products are FDA-cleared, usually range from $175-$300, and, depending on your unique physiology, could help increase your chances of timing the use of an IVI kit. At-home semen analysis tests are also regulated by the FDA, and can often give an indication of sperm health that can help diagnose things like male factor infertility, low-sperm motility, or azoospermia.
At-Home Intravaginal Insemination (IVI) Kits
IVI is quickly becoming the first-line fertility treatment, with companies putting out untested and unregulated at-home IVI kits left and right that haven’t been FDA-cleared for use. Only one of these kits has FDA clearance and 100% guaranteed sterility: the PherDal artificial insemination kit for home use.
Our one-and-only IVI kit is the first-ever FDA-cleared, sterile, at-home fertility treatment, setting it apart from other kits that follow a similar format. It’s a title we’ve worked hard to earn in a market that’s overflowing with less-than-stellar products.
An artificial insemination kit like ours contains three needleless syringes and collection cups to give you the best shot at success depositing fresh or medically frozen sperm at the cervix. This shortens the commute to a waiting egg, fast-forwarding the trip to conception. Our syringe is also designed to reach all the way to your cervix, and the ultra-smooth tipped design prioritizes comfort while maximizing how much sperm makes it through the cervical opening.
In short, you maintain your bodily autonomy without having to compromise on intimacy either, and at $200 per kit, IVI with PherDal is easily your first, best, and most cost-effective strategy for solving the infertility equation.
Your #1 Option: FDA-Cleared PherDal
At-home fertility treatments are opening up a world of possibilities for couples and single mothers by choice who are struggling with infertility. Being able to take control of your fertility from home ensures comfort, privacy, and inclusivity. No approach can guarantee 100% effectiveness, but you deserve a 100% sterile and FDA-cleared IVI kit that puts the power of science-backed results in your hands.
We’re thrilled to share the PherDal kit with hopeful parents everywhere so they can take control of the journey with the confidence a true medical-grade fertility device provides. Our kit has made an important and historic step forward as the new first line of fertility treatment and the only sterile kit available over the counter.
The PherDal family is proud to make the best IVI kit worthy of your trust on this journey.
