Med Device Monday: Reclassification of the Female Condom

Last week we discussed the two different ways for a medical device to be reclassified at FDA. This week we’re going to dive in and give you an example of a recent medical device that underwent reclassification.

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On September 26th, FDA published a final order titled “Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom.” As you can tell by the name of the order, the device has been renamed from a “single-use female condom” to a “single-use internal condom,” effective October 29, 2018. In addition to the renaming of the device— which was done to differentiate it from the single-use internal condom— another change has been made to the device; it has been changed from a class III device to a class II device. This classification and name change comes as a result of newly evaluated information that was not available at the time of the original device’s premarket approval, as well as comments from the public that were received in response to FDA’s proposal to reclassify that came in December 4th, 2017. There were a total of 78 public comments in response to the proposed order from December 2017. The majority of these comments were in support of the reclassification of the device, as well as the name change and the effort to increase patient access to single-use internal condoms.

As previously stated, the device was originally classified as a class III device. Devices that weren’t in commercial distribution before May 28, 1976 were automatically classified as a class III device without any FDA rulemaking, and are traditionally called postamendment devices. Those devices maintain that classification until the device is reclassified. One of the ways this reclassification can occur is if the FDA issues an order that finds the device to be substantially equivalent to a predicate device that does not require premarket approval. FDA can reclassify devices on their own initiative, or in response to petition from manufacturer or importer of the device. FDA relies on valid scientific evidence in the classification process to determine the level of regulation for devices.

The final order highlights that when used correctly, the single-use internal condom is the only female-controlled method that is intended to prevent both pregnancy and the transmission of sexually transmitted infections (STIs). By finalizing this reclassification, the FDA minimizes the regulatory burden on industry, since single-use internal condoms will no longer require premarket approval (PMA). Instead, these devices will require a less burdensome 510(k) prior to marketing.

FDA is making the two modifications to the identification for single-use internal condoms by confirming that they’re over-the-counter devices, and that the device is intended to “prevent the transmission of sexually transmitted infections,” not “prevent sexually transmitted infections.”

The single-use internal condoms have been reclassified to class II with special controls under 21 CFR part 884 for obstetrical and gynecological devices.The special controls established for this device are clinical performance testing, viral penetration testing, nonclinical performance testing, biocompatibility analysis, shelf-life and packaging testing, and labeling. Each of these special controls contains further details and requirements. For example, the clinical performance testing must include the rate of clinical failure, rate of individual failure modes, and the cumulative pregnancy rate when using the device based on a contraceptive effectiveness study. Viral penetration testing is required to demonstrate that the device is an effective barrier to STI’s, and the shelf-life and packaging testing is necessary to demonstrate that the device maintains the performance characteristics and integrity for the duration of the shelf-life. In addition, the nonclinical testing must include both mechanical testing and compatibility testing. That’s a lot, right? But it’s all for a good reason! Reviewers need to make sure that the reclassification is valid, and is being reclassified into the right class.

This is a good example on how FDA reevaluates medical devices as better understand the device’s benefits and risks. For more information on how FDA reclassifies devices, check out our FDAFriday blog post where we discuss “Reclassification.”

Additional Reading:

1.    Federal Register Female Condom Information

2.    Reclassification Information

3. Reasons to Use the Female Condom (opinion)

FDA Friday: Reclassification

The longer you know someone, the more you learn about them. Well, the same goes for medical devices! As knowledge about a medical device increases, we inevitably have a better understanding on its benefits and risks. As our understanding of a device evolves over time, it is possible that the classification of the device might need a little update. There are two different ways for a medical device to be reclassified at FDA, both of which we review below.

First, there is a way for a medical device to be reclassified as described in the Food, Drug and Cosmetic Act (the Act). Under Section 513(e) of the Act, FDA may reclassify a device based on new information, whether it is discovered on their own, or in response to a petition from an interested person. In this case, “new information” is defined as publicly available, valid scientific evidence. If FDA or a petitioner proposes that a device be reclassified to a lower class (say from the higher risk Class III to a moderate risk Class II), sufficient and valid scientific evidence must be provided in order to support the determination. In July of 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was created, which changed the reclassification process to an administrative order process instead of rulemaking. According to FDA’s website that discusses reclassification, in order to reclassify a device under this section of the FD&C Act, FDA must do the following before making the reclassification final:

§  Publish a proposed order in the Federal Register that includes proposed reclassification and summary of the scientific evidence supporting the reclassification

§  Have a panel meeting for the device classification before or after the proposed order has been published

§  Take comments from the public docket into account

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There are also additional rules and guidelines that apply depending on the original class level, and the new class level for a device. For example, for devices being reclassified from Class II to Class III, the scientific evidence must indicate that the general and special controls are insufficient to provide reasonable assurance of safety and effectiveness. Conversely, if a device is being reclassified from Class III to Class II, the scientific evidence must show the opposite; that the general and special controls are sufficient to provide reasonable safety and effectiveness. Lastly, if a device is being reclassified to Class I from either Class III or Class II, the scientific evidence must show that the general controls alone are sufficient to provide reasonable assurance of safety and effectiveness.


The other route for devices reclassification is described in Section 513(f)(3) of the FD&C Act. This originates from the understanding that any device not available before the Medical Device Amendments in 1976 was automatically classified as Class III. This classification was determined regardless of any risk the device posed, and without undergoing any FDA rulemaking processes. These medical devices are more commonly known as postamendment devices. Unlike the process above, these devices may only be considered for reclassification if the initiative comes from FDA or a petition from a manufacturer or importer. Similar to the 513(e) process discussed in the previous paragraph, reclassification of a device can only be made when sufficient regulatory controls can provide reasonable assurance of safety and effectiveness. A device reclassification panel may also be called, should FDA receive a petition requesting reclassification. After all information has been considered, FDA will determine whether the reclassification petition is approved or denied. Following approval, the order describes both the reason for reclassification, as well as any of the device’s risks to patient health.


By the way, if you’re wondering where the whole de novo process fit here, you should check our previous blogs here along with the update here. Keep in mind, a de novo request (per 513(f)(2) of the FD&C Act) is a file where a submitter can request a new classification altogether. Therefore, we don’t really consider it a ‘reclassification’ per the definition of our subject in this blog.


To see a full list of medical devices that have been reclassified since 2013, visit this link. If you’re wondering why the list only goes back five years, it’s because it wasn’t until FDASIA was enforced in 2012 that FDA was required to annually post the devices reclassified in the year prior.


Additional Reading:

  1. Overview of Medical Device Classification and Reclassification

  2. Classify your Medical Device

Med Device Monday- BOSE’s Self-Fitting Hearing Aid

Bose™. You know the name; you blast your music through their speakers, you block out annoying sounds with their noise-masking sleepbuds. And now, they’re making their way into the medical device world! This past month, FDA granted marketing of a new device from Bose: the very first hearing aid that doesn’t require assistance from a healthcare provider. This approval comes after data revealed that the Bose Hearing Aid had comparable outcomes to professionally-fit hearing aids, as well as a patient preference for the Bose Hearing Aid settings over the clinician-set settings.

This new hearing device is approved for individuals 18 years and older who have mild to moderate hearing loss, something that is much more common than you’d probably think. According to this website, there are reportedly around 37.5 million adults in that age range who report having troubles hearing, whether it’s severe or minor. Those with permanent hearing loss have the option to use hearing aids to help hear and communicate better, and the Bose Hearing Aid can do just that, without needing the help and assistance of a clinician. You heard right, Bose Hearing Aids do not require a visit to the healthcare provider, ultimately making this technology even more accessible to patients.

The way that the Bose Hearing Aid works is through air conduction, which captures sound vibrations through microphones. Those vibrations are processed and amplified before being played back through the earphone in the ear canal. With the majority of other hearing aids, they can really only be adjusted manually, but with the Bose Hearing Aids, they can be adjusted through a mobile app on a Smartphone. The mobile technology allows users to personally fit the settings of the hearing aids themselves to fit the various environments they encounter day-to-day all on their own.

Currently, FDA is in the process of creating a new category of over-the-counter hearing aids on account of these new hearing aids from Bose. These hearing aids are yet another innovative technology on an ever-growing list of devices that have been reviewed through the De Novo pathway. Thanks to devices like these, it is becoming clear that the future of medical technology certainly is upon us.

Additional Reading

  1. FDA Press Release

  2. FDA Classification Order

  3. Article by TechCrunch

  4. Bose website

Med Device Monday: ThermoNeuroModulation Device to Treat Migraines

It’s Medical Device Monday! As excited as we are here at AcKnowledge RS about Mondays, it is known by many as #MigraineMonday on social media. Well, today we have some exciting news for sufferers: a stimulator by Scion NeuroStim LLC called the ThermoNeuroModulation (TNM) Device. Although it is currently for prescription use only, it is still a step forward for those who experience migraines.



Over 39 million Americans suffer from migraines; 2-3 million of those 38 million suffer from chronic migraines. During a migraine, a person may experience a variety of symptoms including vertigo, pain, sensitivity to light, or nausea. Some people suffer from vestibular migraines that cause repeated bouts of dizziness and may or may not include headache. Vestibular migraines can also lead to issues with balance, extreme motion sensitivity, vomiting, and feeling disoriented.  

Migraine treatments for traditional migraines are relatively limited; you can take pain-relieving medications or preventive medications, depending on the severity and frequency of your migraines. Pain-relieving medications can range from ibuprofen to opioids. Preventive medications include cardiovascular drugs, antidepressants, Botox, and even anti-seizure drugs. Both approaches clearly involve the use of pharmaceuticals, and unfortunately may not alleviate pain or prevent migraines from happening again.

The TNM Device is a non-drug solution for migraines that was granted through the de novo process in April 2017. Per the device description in the FDA de novo Classification Request:

“The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.”

The device is a non-invasive, home-use, DC-powered device that uses an over-the-ear headset with metallic earpieces that protrude into the external ear canals. While the user reclines and relaxes during treatment, the earpieces change temperature from 16-42°C. The controlled thermal fluctuations interact with the user’s vestibular system, causing changes that are used to treat their migraine headaches. The control unit with touchscreen display allows the patient to manage the treatment.

The TNM Device was studied in a multi-center, triple-blind, placebo-controlled, randomized study. Half of the patients were treated with the device while the other half received a placebo device. After three months of treatment, patients experienced a 21% decrease in total headache pain scores and the duration of migraine days decreased from 7 to 4.

The de novo pathway provided a mechanism for devices such as the TNM Device to undergo FDA review even though there are no other devices like it on the market. We hope that this device can help those who suffer from migraines. After all, don’t we all want a migraine-free Monday/week/life?

Are you interested in the de novo pathway? Check out our original blog post and update about if the de novo pathway is right for your device!

Additional reading:

Med Device Monday: Aethlon's Hemopurifier

Today is our fourth and final post in our October series, and today we’re talking about another Breakthrough Device  that has yet to hit the U.S. market. And since it’s almost Halloween, what a perfect time to talk about Dracula’s favorite topic: blood! The Aethlon Hemopurifier® is a first-in-class device developed for rapid elimination of circulating viruses and cancer-promoting-exosomes from the body. In simpler terms, the device acts like a filter by straining out impurities— in this case, viruses and cancer cells— from the blood. The device has been awarded the breakthrough status because it fulfills one of the conditions for the breakthrough designation; namely, its ability to provide a more effective treatment for a life-threatening or irreversibly debilitating human diseases.

The hemopurifier is a one-time use, disposable cartridge that can be attached to dialysis and other blood circulatory equipment commonly used in health care settings. The entire circulatory system of a patient can pass through the cartridge about one time every 20 minutes. The cartridge consists of a biocompatible plasma membrane (with 200 nm diameter pores) coated with a plant-derived lectin known as Galanthus nivalis agglutinin (GNA). GNA binds to polymeric structures called glycans found on the surface of the viruses and exosomes, capturing them, and keeping them from re-entering the patient’s circulatory system. Viruses and exosomes are known to use this “glycan shield” in order to camouflage and subvert the body’s immune system. GNA selectively binds to a broad spectrum of infectious viruses while having limited interactions with most human proteins. You can really put this into perspective and understand how incredible this is when you evaluate the other anti-viral drug regimens that are used today, and the prolonged amount of time patients must participate in those regimens. Studies have shown that GNA is capable of inhibiting many viral pathogens such as Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Dengue Virus, Ebola Virus and Severe Acute Respiratory Syndrome Coronavirus.

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Recently, we have seen the emergence of new viruses and the reemergence of old viruses that cause severe and fatal infections. The increase of these viruses is often induced by international travel, global warming, and densely populated urban environments. The majority of these viruses have no vaccines or treatments available, and depend solely on the body’s immune system to fight off the infection. Ebola, Zika, and Chikungunya are examples of such viruses capable of causing lethal infections for which no approved treatments exist. The outbreak of Ebola and Zika infections in the recent past are reminders of the need to develop therapies to prevent future epidemics.

Aethlon hemopurifier therapy has been successful in curing patients infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In 2014, the device was successful in treating a comatose Ebola-infected physician. In fact, a single administration of the hemopurifier therapy was successful in saving the patient with multiple organ failure. This led to Time Magazine naming the Hemopurifier as one of the "Top 25 Inventions," as well as one of the "Eleven Most Remarkable Advances in Healthcare." The company is currently conducting pre-clinical studies on mosquito-borne viruses like Chikungunya, Dengue, and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection.

Hemopurifier therapy is also being applied to the capture of exosomes. Exosomes are vesicles that are released by cells into the circulatory system where they are distributed throughout the body. They have been implicated in intercellular communication and the transmission of certain diseases within the body. Compared to normal cells, tumor-derived exosomes (TEX) are released by cancer cells in exponentially greater numbers. TEX is associated with cancer progression, immune suppression and chronic inflammation. In fact, 90% of all cancer-related deaths are attributed to metastasis involving exosomes. Moreover, studies have shown that TEX is resistant to a wide range of anti-cancer drugs. In addition to their role in cancer metastasis, exosomes have also been implicated in the progression of Alzheimer and Parkinson’s, as well as numerous inflammatory diseases. Thus, therapeutic approaches targeting the exosomes, such as the hemopurifier therapy, address a significant unmet need in the medical field.

It is devices like the Hemopurifier that FDA aims to safely get on the U.S. market. Breakthrough Devices often offer solutions for diseases where no cleared or approved treatments exist, or they provide significant advantages over already-existing therapeutic approaches. Clean blood is something both patients and Dracula can smile about!

Have a safe, effective, and happy Halloween, everyone!

Additional Reading

  1. Aethlon Medical Website

  2. Press release for Athleton Breakthrough Status

  3. Breakthrough Devices Program

  4. Info about Dracula