I'm about to finish up a senior project and about to demo it very soon. One of the assignments I needed to complete was to classify the device based on what the FDA would think of my device. At first it seemed like I knew exactly what class it was, but as I examined my device more as well as what the classes actually entailed, I became very confused. I asked Dr. Simon for advice and he helped me in solving this dilemma by suggesting de novo 510k, because my device was significantly novel and really didn't have any predicate devices. I had to really examine what this device was and what the FDA would assume was its main purpose.
So my question to you guys, have you every worked on a project or a medical device and the line between device classification was blurred? If so, how did you solve the issue of classifying the device based on FDA standards?
My capstone project was one that we were not sure if it would even go through FDA regulation. My capstone project is a mobile application that helps train users to discriminate auditory cue, such as discriminating pitch. We were also asked the question in my capstone class what class would our project fall under for the FDA. So, my team and I were not sure because our project was an app, but it is training someone’s hearing. Our app was equivalent to the FitBit, which is a device that monitors someone’s health. We conducted a Google search and we came across a whole new FDA classification called mobile medical applications. FDA said for a device to be considered a mobile medical application it has to be used in conjunction with an external medical device. For instance, if our app worked in conjunction with hearing aid. Then, it would be considered a mobile medical application. However, at the time the intended use of application was for people who had a hard time hearing or for people with normal hearing with a little hearing loss. Therefore, we learned that our app would not fall under any class or category.
Last year in medical device course, I submitted a project proposal on device called “Indirect Video Laryngoscope”. The purpose of that device is to make the process of intubation easier and quicker to perform. It can also be used for detailed examination of larynx and vocal cords. Indirect Video laryngoscope advance in technology helps doctors visualize closely and obtain bright and sharp image of vocal cords, and glottis. Uniqueness of this device is the distal chip technology has digital photo and video recording capability which helps eliminate separate camera assembly as in previous laryngoscopes. It also improves clinical practice, patient safety, less time required, easy to learn and perform, and highly successful techniques. Before my project proposal, I was very confused between class II and class III devices. After research, I found that it is a class II device which required 510K with clinical trial because that device was already in the market passed FDA regulations. I am assuming if my device causes any internal damage to patient then it would be class III with PMA required.
In one of my projects at NJIT, my group member and I were tasked to come up with an innovative medical device as a final project. What we had decided on was a wearable device that had the ability to measure blood-glucose levels while relaying the obtained data to a mobile app on the patient’s phone. In the beginning, were very confused on what classification this idea would fall under. After all, it did not seem to fit any one of the three main classes generally discussed so it was initially decided that no FDA regulation would be required. After doing some research, we too had discovered as previously mentioned by djr32 in an above response, that our product would be classified as a mobile medical application. This is because we had both a medical device actively measuring and relaying the data to application located on the patients phone which would display the data in an organized way.
https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368744.htm
Similar to Davids's situation I was in the same class and our final project was a novel prosthetic arm. Our proposal was the development of new types of soft robotic structures, especially materials/methods for the fabrication of such robots, involving biomaterial science and robotics. The goal was to increase current standards in limited range of motion and create a more natural integration point for the soft robotic implantation. We thought that the regulation within this would be at the very least a Class II Device since there were predicate prosthetics and this was similar to those and with the electronic and mechanical component this would have a greater risk associated than a Class I Device. To our surprise while researching and putting together the proposal the classification for this device turned out to be Class I General Controls.
At the company I work for, we are constantly developing prototypes and special products for customers based on existing devices that we have filed for. In order for us to determine the approval pathway, the regulatory department uses a flowchart/decision tree provided by the FDA in order to determine which classification the device will fall under. This process is mostly reserved for new products. Products that are minor modifications of existing products typical do not require approval. This places increased pressure to achieve results without introducing too large a deviation from the existing, approved device.
During my work experience, if we need to file for 510k or FDA approval, we use the flowchart developed by the company and the FDA to guide us during the entire process. The process is so broad that there are multiple steps and different classification of device before submitting an application for an approval. At many times, if it’s a family of parts or a component of a previously approved device, we refer to the old application filed for guidance. Lastly, it can be a challenge differentiating medical devices into its classes, but it’s very important for a company to classify the device accurately.
This year my senior capstone project focuses on the attachment between a polyethylene component and tibial implant used in total ankle replacements. There is currently two piece total ankle replacements on the market, so our device would be classified as class 2. However this is still a lot of testing for our team to complete in capstone to show proof of concept. If this design is used in industry it would follow a class two device protocol.
To solve the issue of classifying the device based on FDA standards product should be characterized as a drug, device, biological product, or combination product, most of these issues have related to whether a product should be classified as either a drug or a device. Accordingly, this guidance focuses particularly on cases in which a product may be classified as a drug or device. Additional issues relating to product classification, including how to obtain classification determinations from FDA for medical products.
I had the same experience with my capstone project. We were really confused on what class it would be considered. On the other hand we had so many different components, that we had to do research for each one separately. Our project was a medical device that was able to measure blood oxygen level, heart rate and blood glucose levels. Ultimately, most of these sensors are considered as class II. After looking on the FDA website realized that most of the sensors we had are all considered class II. Initially, we all ruled this a class I, because it did not seem like these sensor could be considered class II.
I currently work at an orthopedic company. We recently had to make an update to insert a class III PMA logo for all level III medical device. Since I had to go through several devices, I did not want to ask my manager about each one and tried to figure them out myself. I actually found the FDA website to be useful, it has a section on how to determine classification. From here you can either use the classification database (where you can search for part of the device name) or the device panel (listed by speciality).
The writer is finishing up a senior project and needed to classify their device based on FDA standards. At first, they thought they knew what class it would fall under, but upon closer examination, became confused. They sought advice from Dr. Simon who suggested a de novo 510k since the device was significantly novel and did not have any predicate devices. The writer had to examine the device and determine its main purpose in order to properly classify it. The writer asks if anyone else has experienced a blurred line between device classification and how they resolved it.
My Capstone project also had my team reconsidering if our device would even need an FDA classification. Our product was a microfluidic device that was to be used in laboratory applications to help stem cells differentiate into chondrocytes. At first, we thought that it would be an FDA regulated product as the end goal of this device was to help grow these cells that could later be used for engineering tissue that can be used on a patient. As we dived more into the regulations, it seemed that our product would not be regulated by the FDA as the product itself was not being interfaced with patients. It is equally surprising seeing what the FDA regulates and what it doesn't regulate. We were able to determine that it was not FDA regulated by looking closely at the FDA website and then further comparing our devices to similar ones on the market. We searched up the devices on the market against the FDA database and saw that it was not regulated.
Similar to your situation my capstone team and I also struggled to classify our device when asked to do the same assignment. As group, we probably changed our devices classification two or three times the more we thought about it. Our device was a motorized femoral hook lift that would be utilizing to help a surgeon lift the proximal femur during total hip surgery. The medical device was intended, more specifically, for the assistance of femoral stem insertion during a direct anterior approach for the total hip replacement surgery. Our initial thoughts were that the device would be a Class III medical device just from the fact that it would be used during surgery and be used inside the body, but after some research of the FDA's classification such a device was more so a Class I device than it was a Class III. Because our device was fairly novel we did not find any devices that we could emulate in classification, but instead we found similar devices with the same intended use. These devices were classified as Class I devices. In the end we determined that our device would be a Class II device because it includes some electrical components such as a motorized actuator which can be classified as a moderate risk during surgery. The device will be moving up and down while holding a patient’s femur, forcing safety precautions to be taken when controlling the device. Overall, it was determined that our device is not a Class III medical device because it is not life supporting or sustaining, but rather just an assistance for the surgeon to better perform the surgery, and it is not a Class I medical device due to its moderate risk and specialized indication. Did we make the right decision based off the brief description below?
I have theoretically worked on a device for a presentation in Biomaterials. The device would deliver sunscreen to people suffering from albinism through a monitoring process similar to a blood glucose monitor. The sunscreen would be delivered through patches on the skin but the number of melanocytes would be monitored subcutaneously. Initially, there was confusion for the team in terms of designating it as Class II or Class III, but with the help of our professor, we figured out where it should be placed.
