One of the major determinants of the length of a project for a medical device would be whether the goal is to obtain a 510(k) clearance or a PMA. To obtain a 510(k) it is only necessary to demonstrate that a device is substantially equivalent to a device that was developed before 1976 (when the Medical Device Ammendments went into effect granting the FDA authority over medical devices) or a device that is already approved as a Class II device. A PMA needs to demonstrate safety and efficacy, with support using clinical data via a clinical trial. This is obviously much harder, takes longer, and is more expensive to complete compared to a 510(k), and as a result many companies will try to get new devices cleared as via a path of substantial equivalence. My question is how far can you embellish how similar a new device is to a predicate device? What ethical responsibilities lie with the company when they take this risk? Given that fraudulent 510(k) notices are a felony offense, this issue is taken very seriously with the FDA.
I think if the company wants to be successful, they need to take the regulatory submission process seriously and not embellish how similar a device is to a predicate device. Substantial equivalence means that the new device is at least as safe and effective as the predicate, a legally U.S. marketed device. As per the FDA website to be considered substantially equivalent in comparison to a predicate it:
"has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and does not raise different questions of safety and effectiveness; and
the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device."
The new and predicate device do not have to be identical but substantial equivalence can be established with respect to intended use, design, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility,etc. I would expect a company to provide the true information when submitting to the FDA, if they have plans to be a successful company. Trying to pull a fast one on the FDA isn't the smartest idea because they can perform inspections and audits and the ultimately the truth will come out sooner or later. A device cant marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent from the FDA. If FDA determines that a device is not substantially equivalent, the applicant can resubmit a 510(k) with new data, go through the DeNovo Classification process, file a reclassification petition, or submit a PMA.
Overall, I think its in the company's best interest to act in an ethical manner. Trying to submit a fraudulent 501k notice to avoid class III Premarket approval processes, may seem like a route to save the company money and time to get to market, but ultimately it could cost them everything with being shut down by the FDA in the long run for a fraudulent submission.
As said for obtaining 510(k) the only requirement is to show that the instrument is similar that was developed before 1976 and they are classified under class 2 devices, but for PMA there has to be more trials on humans or animals and documents about its efficiency and safety has to presented supporting the experiments or we say trials done on humans. PMA is harder both economically and time wise to complete the whole process so many companies clear their devices through 510(k).Answering your question I think that necessarily the new device should be as safe and efficient as the predicate one.There may be something in common like use and technological characteristics or common use but different technological characteristics though having no question of safety and efficiency. Claiming substantial devices does no actually means that they should be identical. It is established in regards to the use, energy gained-required-delivered, materials used, manufacturing process, performance, effectiveness, safety, biocompatibility, standards and many other.
I completely agree with Alexendrabuga, if a company want to be successful and if a company would think for a long term life of the company then they should not fraud by choosing a shortcut instead they should go with the regulations and whole procedure ethically.
I would like to add to the discussion by talking about my experience with 510k submissions. It definitely is possible for companies to embellish characteristics of an implant or testing results to claim equivalency to a predicate device. We had a situation at work where we bought out a startup company that had a device that was currently being marketed and had been approved through a 510k. We replicated the testing that they had performed on the device and were not able to get similar results to the data that they had submitted to FDA. However, when companies act unethically like this, they are taking a high risk of having product failures in the field, and this product that I mentioned earlier is a good example of this. After we acquired the product, it had multiple issues in the field, and we ultimately had to recall the product.
I agree that it would be unethical for a company to embellish their product to try to get it classified as a type II device rather than a type III device because of the large risk associated with class III devices. The company runs the risk of negative affects from their device if it hasn't been properly tested for its proper classification. Without proper testing an unsafe device can end up on the marker which could result in severe consequences. I also think it would be in the company's best interest not to embellish the product in the first place because it also runs the risk punishment by the FDA if figured out.
FDA 510(k) submissions are for class II devices that have already been approved in the market since the FDA passed the Medical Device Amendments Act in May 28th, 1976. When submitting a 510(k), the device must be compared to other legally marketed devices in the U.S.. 510(k) submission requirements are detailed in 21 CFR 807 Subpart E. IF the FDA does not believe that the device is substantially equivalent to a predicate device, then either a new 510(k) submission with new data, request for Class II designation (De Novo), file for a reclassification petition, or a pre-market approval (PMA) is necessary. A De Novo classification request is based on general controls that provides assurance of safety and intention of use, for devices that do no have legally marketed predicate devices. Only Class I and Class II devices, based on risk, are eligible for De Novo requests.
In the event that you are modifying a device to the point where you may need to have software modification, it will need validation. If it is a modification that do not need animal testing but may still require a higher level of safety when in use before the modification it may require just as much work and a class III device when going through the validation. Also, if the device is a combination or my be very unique it may need peek some interest with the FDA and may require a greater deal of explanation. This process can be timely and can be comparable to a class III device.
As Dr. Simon discussed in his lecture videos, the clearance of a Class II device can at times be as costly and timely as a Class III device. Certain Class II devices will require a investigational device exemption (IDE) to support the safety and effectiveness in the 510(k) application. An IDE must be approved by the FDA to perform clinical trials on a medical device that poses a "significant risk", i.e. a device that poses a serious risk to the health, safety, and welfare of a patient. Even if the device does not pose a "significant risk", the IRB must approve an investigational plan before conducting clinical trials. Now, if the 510(k) application for the device is rejected and is therefore classified as Class III, a 510(k) resubmission or a de novo application can be submitted to reclassified the device as a Class II. If the FDA finally clears the device as Class II, the risks of a postmarket failure are higher than if the product was approved as a Class III product through a PMA. A postmarket failure will result in a product recall and cna result in total costs that could very well exceed the expenses of obtaining a PMA.
When bringing a medical device into market company will determine whether to submit 510(K) or PMA. If the company could not make right decision getting unsafe product in customer's hands causes serious damage and product failure. The class II devices are important for healthcare but also have less risk to user requires 510(K) submission while the class III devices are mostly implanted devices whose malfunction can cause adverse outcome for patients requires PMA before marketed . For 510(K) submission you needs to prove that your device equivalency to a predicate device ,no clinical trials are required .For PMA ,it should be proved that new device is safe and effective which requires clinical trials .The 510(K) submission can be used to reduce time and cost in case of device where there is no concern of safety and health. PMA is more time consuming requires number of clinical trials and each step should be documented proving reliability and GLP must be followed which cost millions of dollars. There is huge difference between complexity and length of document between 510(K) and PMA. Medical device manufacturer found it difficult which submission should be sought. The company should wisely decide the right path for submission before product being marketed.
It is not in the best interest of any company to try to deceive or commit fraud in classifying their device as it taints all future submissions to the FDA if they are even allowed to continue operating. Additionally it raises many ethical concerns regarding their decision making and in my opinion safety concerns of all their other products already on the market. Medical Device companies should remain grounded in their duty to the general public, the people that will be using these devices and who have faith that their device will provide them a better quality of life. If the misclassified device makes it to the market and starts causing problems, the company could be faced with serious repercussions depending on the severity of the problems.
I don't have much experience with any of this as I'm still an undergrad, but is it at all possible to accidentally misclassify a device and the FDA approving it? If the FDA realizes their mistake what would happen to the company? Not sure if this has ever happened before.
This is a good question, that I wondered myself. It seems that there is a significant advantage in the timeline of developing a product if a product is labeled as class 2 rather than class 3. For products that have the risk factor of class 3, but are granted class 2 classification due to the fact that a similar product has been on the market seem to have a lot to gain from stretching the truth about how similar they actually are to another product in order to pass on inspections and clinical tests. However, this would be both hard to do in the first place, and could also drastically backfire on the company if there was to be a safety issue or recall on the product due to the lack of inspection and testing done in pre-market. For this reason, I think there is no need to adjust the classification system.
There are many important aspects in project management (including how long a project will take and the cost of the project) that are dependent on whether a device is classified as Class II or Class III. We learned this past week about how if a device can demonstrate substantial equivalence to another device already in the market as a Class II device, that the new device can be classified as a Class II device as well. A Class II classification would be ideal for most companies and projects, but to what degree does substantial equivalence extend? Another user had mentioned the specific definition that the FDA provided, but this description still seems very broad to me. It sounds as if how a device is classified is dependent on how the device’s function and purpose is explained to the FDA. Obviously, there are questions about ethics that arise from this topic as well. I wanted to know what others thought about this.
Interestingly, this question was brought up in another graduate class I took at NJIT where we looked at the creation of orthopedic implants. My professor wanted us to create unique orthopedic implants through CAD modeling but stressed the importance of finding an implant already established within industry and making slight changes to it. He mentioned to us that this was a common practice he had witnessed since it would speed up the approval process when facing FDA approval.
Like many of my classmates have mentioned, no company should have to consider “embellishing a new device” in order to complete a 510(k) rather than a full-on PMA, it can be representative of how serious or not that company may be. The most appropriate measures should be taken for the appropriate classification of the device. If a device I was developing was on the fence between needing a 510(k) or a PMA, with the resources at hand, I would rather take the more conservative approach and complete a premarket approval. If the FDA comes back after having completed a 510(k), requiring a PMA instead, that would create double work for my company, ultimately costing the company more money for the new work to be done.
In regards to what extent one can embellish how similar a new device is to a predicate device, this all relies heavily on how similar the new device is to the predicate device. If a novel feature is being included to this device that has never been seen before, then the classification of the device would have to be re-considered and the appropriate measures must be taken.
My question is how far can you embellish how similar a new device is to a predicate device? What ethical responsibilities lie with the company when they take this risk? Given that fraudulent 510(k) notices are a felony offense, this issue is taken very seriously with the FDA.
Many of the previous replies to this thread summarize the overall theme of submission of fraudulent 510ks and have gone through the steps on why it would be hard for a company to embellish a false submission path due to the rigor and cost on having to submit a PMA post 510k submission. In terms of the risk associated with embellishing a new device to a previous, there isn't too much risk as long as you don't start to add a type of drug delivery or electronic implantable to a class II device. There are bounds before a class II becomes a class III device (even class II has a large amount of specifications on types of class II devices) that would become evident for one who works in the industry. Many companies will "copy" designs similar to a competitor not only for less rigorous verification and submission, but also because they want to take the market share the initial company has taken in that sector of the business. Most companies, both from ethical and business standpoints, would take responsibility in submission routes and how they want to choose the class of their device.
Another reason why many companies wouldn't submit an incorrect submission path is the fact that many in the industry are morally driven to help the patients who are using that said medical device. People are morally guided are or have a large amount of compassion in doing the right thing when they are working with life changing devices.
