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

 Image from https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm378724.htm

Image from https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm378724.htm

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.

 IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

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: Breakthrough Device VectRx by NeoTherma Oncology

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

The next device in our series is called VectRx™, a Thermal Treatment (TTx) system being developed as an adjunct therapy for solid tumors. This device comes from Kansas-based device maker, NeoTherma Oncology, and has been granted FDA breakthrough device designation for treatment of pancreatic cancer. The company prides itself in providing a “more effective and more humane solution for treating cancer.”

From the www.neothermaoncology.com website:

“Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. The energy emitted by our TTx device increases blood perfusion in tumor micro-environment, reversing the treatment-resistant hypoxia, and promoting a therapeutic immune response.”

Hold up…let’s back up a minute and talk about cancer…chances are, you or someone you know has been directly affected by this disease. According to the American Cancer Society’s recent report, in 2018 alone there will be an estimated 1,735,350 new cancer cases diagnosed and 609,640 cancer deaths in the United States. This disease is defined as the uncontrolled division of cells in the body. Many cancers form solid tumors, which are abnormal masses of tissue, and can either be benign (non-cancerous) or malignant (cancerous). Solid tumors are named for the type of cells that form them, and include sarcomas, carcinomas, and lymphomas. Treatment for solid tumors is generally a combination of surgery, chemotherapy and radiation therapy.

Pancreatic cancer — statistically known as the deadliest of the solid tumors — is the fourth leading cause of cancer-related death in both men and women. The NIH based National Cancer Institute estimates that 55,440 new cases of pancreatic cancer will be diagnosed and 44,330 deaths will be associated with the disease this year. Last year there was an estimated 43,090 deaths caused by this type of cancer and researchers place the 5-year relative survival rate at a meager 8.5%. Radiation therapy and chemotherapy are currently the main treatment options for pancreatic cancer. Unfortunately, less than 20% of patients are candidates for surgery because pancreatic cancer is often detected well after it has spread beyond the pancreas. Enhancing the efficacy of existing therapies is one crucial way that scientists and doctors can improve treatments for this deadly cancer. With all these stats in mind, it’s not hard to see why FDA designated this product as a Breakthrough Device. It clearly meets the first criterion that states it “provide a more effective treatment for a life-threatening or irreversibly debilitating human disease” [emphasis added].


As mentioned above, the VectRx device provides a radio frequency thermal treatment to raise the temperature around the tumor from 37°C to ~42°C. This localized increase in temperature at the tumor site can support the chemotherapy treatment by increasing the blood flow around the tumor (thus enabling the drugs to penetrate the tumor at lower doses). Warming up the tumor site also likely provokes a therapeutic immune response by increasing the tumor cell surface proteins. Helping make the chemotherapy drugs more efficacious while making you feel less cruddy, along with triggering the body’s natural defense system to attack the tumor, equates to a serious ‘one-two punch’ combination in this fight against cancer! It’s exciting to know that VectRx works at increasing the efficiency of the available treatments, while simultaneously minimizing the harsh effects that those treatments have. The device is being developed for treatment of a wide range of cancers, but the lead target for the company right now is pancreatic adenocarcinoma.

Although surgery, radiation therapy, and standard chemotherapy will continue to play an important role in treating cancer, the emergence of novel adjunct therapies like VectRx will expand the treatment options available to cancer patients. We’re excited to see how FDA and NeoTherma Oncology work together to bring this potentially game-changing treatment to the US market.

Additional Reading:

1.       More info about NeoTherma Oncology

2.      Press Release about VectRx’s Breakthrough Designation

3.      More info about Pancreatic Cancer from NIH National Cancer Institute

4.     NeoTherma Oncology secures grant from National Cancer Institute

Med Device Monday: Help for Dry Eyes by AesculaTech

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

We start this month with AesculaTech, named after Asclepius, the Greek god of healing. This LA-based biomedical startup is developing a thermally responsive hydrogel for treatment of dry eye syndrome. Dry eye syndrome is pretty much what it sounds like: a prolonged absence of adequate lubrication and moisture on the surface of the eye. Symptoms of dry eye include constant eye irritation, stinging, burning or scratchy sensation in the eyes, sensitivity to light, redness and blurred vision or eye fatigue. There are a host of factors that increase your risk of having dry eyes, including prolonged computer use, frequent flying, birth control pills, smoking, contact lens wear, diabetes, arthritis, antihistamines, allergies, and aging. So pretty much “living” can lead to dry eye! A 2012 Gallup poll showed that more than 26 million Americans suffer from dry eyes, and this number is expected to increase to more than 29 million within 10 years.

There are prescription medications as well as over-the-counter (OTC) eye drops currently used for the treatment of dry eye syndrome. Unfortunately, many prescription medications need to be used for a long time before any improvement in the condition is evident, and OTC eye drops (artificial tears) only bring temporary relief and require frequent reapplication.

AesculaTech’s propriety material, the AesculaGel, is unique in that it can achieve three different states of matter. AesculaTech co-founder and chief science officer Niki Bayat refers to the AesculaTech Gel as “Reverse Chocolate” as at low temperatures, the AesculaGel is a liquid. However, as it warms up it turns into a gel, only reaching solid state when it hits body temperature.


To simplify, the liquefied AesculaGel is injected by your doctor into your tear duct which then solidifies as it reaches body temperature. A tiny plug forms that prevents tears from draining away from the surface of the eye. This procedure is intended to be performed during a quick, in-office procedure and last for about a year.

Pre-clinical animal trials using AesculaGel have shown statistically significant increases in tears in the eyes. The company is now preparing for human clinical trials before a pre-market submission to FDA.

According to Aesculatech, AesculaGel is initially being tested for the treatment of dry eye syndrome but there are plans to use the gel for the treatment of glaucoma. According to Bayat and co-founder Andrew Bartynski, AesculaGel has a wide range of potential applications, including pharmaceuticals, medical devices, cosmetics, and textiles. Moreover, since AesculaGel could be used for sustained, localized drug delivery therapies, patient non-compliance to drug regimens to treat chronic conditions could also be potentially addressed.

Additional Reading:

1.       More info about AesculaTech

2.       Future plans for the AesculaGel for drug delivery

3.       More info from NIH about Dry Eye