What Does it Mean to Be "FDA Approved"?

In the blog post "Putting Cloth Pads on the Market", it was briefly touched upon that medical devices have to go through an expensive reviewing process under the Food and Drug Administration (FDA). This post will go more into detail about the entire process.

How are medical devices categorized?

The FDA categorizes medical devices into one of three classes: Class I, Class II, and Class III. Class I devices have the least amount of regulatory procedures and include anything that are low-risk such as menstrual pads. Class II devices are considered to be moderate-risk such as tampons, menstrual cups, and menstrual discs. These have to undergo more stringent review processes and may require clinical trials to prove they're safe and effective. In other words, "the benefits of the product outweigh the known risk for the intended use" (U.S Food and Drug Administration). Class III devices are anything that can support and sustain human life so they undergo the most intensive clinical trials. A Premarket Approval (PMA) submission is required. Before an e-copy was available, it would cost companies several thousands of dollars just to send it back to the FDA since there were binders upon binders of pages.

I wanted to learn more about which products are considered Class I and Class II. Class I devices include dental floss, nonprescription sunglasses, bandages, stethoscopes, and wheelchairs. Class II devices are comprised of syringes, contact lenses, insulin pumps, and blood pressure monitors. By this point you may be thinking the same thing I am:

Why is it that menstrual products are the only uninsured medical devices that half the population needs on a frequent basis for most of one's life?

Whether something is classified as a medical device is heavily weighed on how a product is labeled and advertised through brochures, websites, manuals, or posters. A good example would be cotton swabs. Manufacturers can actually claim that they are being used for cosmetic purposes which means the cotton swabs would not be considered a medical device. However, if they begin advertising the cotton swabs as things that can be used in hospitals and affect body function (eg. applying ointment to disinfect a wound), then they are making a medical claim and will thus be considered a Class I medical device.

How do manufacturers register with the FDA?

All manufacturers producing medical devices must be registered whether they are domestically shipping or importing to the U.S. Their name is then documented and publicly viewable on the FDA's establishment registration listing. When businesses are documented in a database, this allows consumers to be protected under a program called MedWatch where they can report any dangerous issues with a registered medical device.

Each year, an establishment must pay a registration fee which continues to increase. As of 2020, this fee is $5,236 while in 2019 it was $4,884. In addition to having to pay this $5,236 fee, people selling Class II and some Class I products (eg. mechanical wheelchairs & examination gloves) are mandated to pay a 510(k) Premarket Notification fee every time they put a new item on the market. As of 2020, the 510(k) fee for small businesses is $2,899 and the standard fee for larger corporations is $11,594. The submission form for the 510(k) alone can be over a thousand pages. Then, a representative manufacturer and packager must be registered to report any malfunctions with a product. These mandatory reports along with voluntary reports about any suspected device-associated deaths and injuries allow the FDA to weigh the risks and benefits.

Getting FDA Approval

When I saw companies emphasizing that their products have been approved by the FDA, I envisioned businesses undergoing months of testing and then sending that item to FDA people in lab coats to do some sort of extra Sherlock Holmes investigation. The reality is that the FDA relies only on test results submitted by manufacturers. Virtually all Class I and Class II devices are only FDA cleared and there's a pretty big distinction. As mentioned before, because Class III devices are high-stakes, results from clinical trials must be submitted to show without a doubt that a device is safe enough for use. This is when the FDA either approves or doesn't. On the other hand, Class I and Class II devices are "cleared" by the FDA meaning that they were able to show that their new product is similar to a previous item on the market that has been cleared or approved of. All that's saying is if you can argue what you're commercially distributing can work in the same way as another one that's being sold and you can afford the fees, then you're good to start selling. Everything that's registered has a 3-digit product code to show that it falls within a pre-existing category. For example, there's HHE (menstrual cups), HEB (unscented tampons), HIL (scented-deodorized tampons), HHD (unscented menstrual pads), NRC (scented-deodorized menstrual pads), NUQ (reusable menstrual pads), and so on.

Consumers fall into the idea that anything going through the FDA is safe, but there are ethical and safety concerns raised with these clearance procedures. What ends up happening is similar to when you try writing an analytical paper having only read SparkNotes instead of the original book. You miss the small but important details. There are companies who have piggy-backed off of FDA-cleared designs who piggy-backed off of designs before them. This trend can be traced back to the original device which could have been created several decades ago. The problem is that there are items that have been taken off the market because there were enough reported incidences. Meanwhile, there are still newly FDA-cleared models being used that never underwent clinical testing and mimic devices no longer being produced.

Long story short, no menstrual product has been "FDA approved". When brands state that their pad or menstrual cup has been FDA approved, they usually mean the materials are approved----not the menstrual product itself. For example, menstrual cups should be made of medical-grade silicone which is anti-bacterial and hypoallergenic. By a company saying they've been approved, it doesn't tell the buyer anything about the successful design or construction of the menstrual cup or even a cloth pad.

Full Transparency

Over the recent years, menstrual health activists have been calling for manufacturers to disclose individual ingredients used in their products. The argument usually made by the FDA and other large menstrual product corporations is that more toxic chemicals come from our food rather than menstrual products. If that's the case then what's there to hide? After all, food manufacturers are required to list ingredients on their packaging in order of predominance. Yet, the FDA still refuses to instill this mandate on menstrual product manufacturers. Saying things are dermatologist or OB/GYN tested and recommended doesn't mean anything. It doesn't tell you how many people tested it or account for the sensitivities some consumers may have to the product. The claim itself doesn't create transparency to the consumers about ingredients used in disposable products which keeps consumers from making decisions on their own personal health. Currently, the only piece of information that must be labeled on the packaging is whether the pad or tampon is made from cotton or rayon.

There's a bill in legislation that was pushed for by Grace Meng demanding companies to label everything going into their pads and tampons. It seems like it's going to be a while before it's passed, but until then, may corporations enjoy their monopoly.

Works Cited

L., Hannah. “Is Pixie Cup FDA Approved?” Pixie Cup, 25 Apr. 2020, www.pixiecup.com/is-pixie-cup-fda-approved/?gclid=EAIaIQobChMIkOvfmNnX6gIVRdbACh3phQKgEAAYASACEgJWTPD_BwE.

Mitroff, Sarah. FDA Approved vs. FDA Cleared: Why You Need to Know the Difference. 13 June 2019, https://www.cnet.com/health/fda-approved-vs-fda-cleared-whats-the-difference/#:~:text=Class%20II%20and%20Class%20I%20medical%20devices%20are%20usually%20%22cleared,products%20are%20called%20a%20predicate.

Overview of Medical Device Classification and Reclassification. U.S. Food and Drug Administration, 19 Dec. 2017, https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification

Rabin, Roni Caryn. Period Activists Want Tampon Makers to Disclose Ingredients. 24 May 2017, https://www.nytimes.com/2017/05/24/well/live/period-activists-want-tampon-makers-to-disclose-ingredients.html

RegistrarCorp. "FDA 101 for Medical Devices." YouTube, presented by Mirna Salmeron, 20 Sep. 2018, https://www.youtube.com/watch?v=AleMkAK_B98

Vorwaller, Justin. The Difference Between FDA Registered, FDA Approved, and FDA Cleared. 17 Jan. 2020, https://www.theralight.com/the-difference-between-fda-registered-fda-approved-and-fda-cleared/#:~:text=FDA%20Approved%20means%20that%2C%20through,devices%20as%20%E2%80%9CFDA%20Approved.%E2%80%9D