To a layman, a surperficial assessment of 510K process is that it is nonsensical.
WHY are devices being compared to devices created 40 years ago.
This makes no sense to me. Why arent the just assessed on their own merits.
This seem like more foolish government process that make NO common sense.
This approach seems to promote unnecessary contorting of descriptions of medical devices to conform to equivalence which may not really be relevant. Consider patents, it is not necessary to make current patents appear to be similar to a previous one. The FDA approach seems silly. Really makes NO SENSE to me.
Will you please explain what is merit of comparing devices to those made 40 years ago?
I think the FDA heard your complaint, because beginning in 2019, FDA began making significant revisions to its 510(K) process to simplify the procedural steps and acknowledge that with the rapid advancement of technology, it makes more sense for new medical devices to compare themselves to more recent device development than many of the archaic designs from 1976.Even the change to declassify medical support software as medical devices is a step that brings more clarity and specificity to what is a medical device. On balance, these regulation changes by the FDA will streamline the processes for both 510(K) and pre-market approval applications (PMA).
I agree that many new medical devices have no business being compared to 40-year-old devices. One of the primary benefits of a 510k is to bypass long and expensive clinical trials. So truly "new" developmental technology has no business being compared to old technology.
However, I don't believe the existence of the 510k is completely out of place. Basing research off legitimate predicate devices can eliminate redundant research and hasten the development technology. The "contorting of descriptions of medical devices" is dangerous and ruins the point of the 510k.
I do see what you mean but I understand the purpose of the 510(k) form. Ive said before, science and medicine is always changing along with our understanding of the body and devices. A device will never last forever and there is always room for improvement. While it is important to assess a product by its own merits, a class II device is a class II device because it is based on another (predicate) device. If all devices were perfect and all that was needed was new (Class III) devices, then I would understand the uselessness of the 510(k). However, its important to see how a device relates with another device that worked well.
I would have to agree with @jonwil123 here. I see the importance in having the 501K approval for some devices that have proven enough clinical significance as an old one. Perhaps the same company that released the device 40 years ago has made it better and improved the way it works. I don's see why the company would have to through a Class III evaluation in order to release an improved device. Moreover, if the device that was released utilized newer technology to perform its function, then wouldn't the efficacy of the technology used have to be tested, not the device? If the technology is approved and the new device is just an improvement, I can see 501k clearance being an option.
To a layman, a surperficial assessment of 510K process is that it is nonsensical.
WHY are devices being compared to devices created 40 years ago.
This makes no sense to me. Why arent the just assessed on their own merits.
This seem like more foolish government process that make NO common sense.This approach seems to promote unnecessary contorting of descriptions of medical devices to conform to equivalence which may not really be relevant. Consider patents, it is not necessary to make current patents appear to be similar to a previous one. The FDA approach seems silly. Really makes NO SENSE to me.
Will you please explain what is merit of comparing devices to those made 40 years ago?
The only thing I can think of is using it as a measure of growth. The standard 40+ years ago is clearly not what it is today, but perhaps making the comparison will be useful to show the growth over time. As a teacher, it is not uncommon for me to give a pre-test for baseline results followed by instruction and then a post-test to measure growth. I think the merit in making the comparison between devices over decades is similar to the implementation of the pre- and post- assessments in education.
I agree with the initial statement made regarding this topic. I believe that all medical devices should be assessed at there own merit, especially due to advances in technology. However, I do believe when medical devices are being developed, they should be compared to older versions of the medical device, so that the changes can be made. Currently there have been changes made regarding the 510k and there are simpler steps that do not require compare to equivalent devices.
The merit is very limited, and you actually make a really good point. At a minimum, there should be a "time-out" period where comparison to products over a certain age are disallowed. Medical innovation is happening so fast. From the compounds used to make the devices to the mechanism of action. The use of predicate device must keep up with the times. Perhaps this rule is really to the benefit to FDA. It would be interest to understand why the FDA consider the approach as a best practice.
Very good point! I totally agree that a new device should not be compared to a device that was approved 40 years back. Science and technology has been changing and so are our approaches to the research. However, I think there are certain scenarios where 510K can make a company easier to launch their updated products. Where a medical device takes years to launch, an updated version of that products can launch quicker by simply being compared to its older version. That can save, time, effort and money.
Your post here is very insightful as I did not know there was a MASSIVE change regarding what is a 510(k) in recent years. For others who want read the exact details on the amendment, the new process is coined as the Safety and Performance Based Pathway. Essentially, what it entails is that no longer do companies need to have a predicate device which was commercially available before 1976. Now, there is a set criteria which if aligns with the safety and performance characteristics of the new device, should grant approval. This is basically modernizing and simplifying the process, in order to actually make sense as time moves forward.
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I feel in principle the 510k approval process makes a lot of sense. If you want to improve upon an existing device that has already shown to be safe and effective, it would be excessive to undergo the the full FDA approval process. The fundamental design and overall function of many medical devices have not changed in 40 years. The new additions such as better attachment and strength are additions that are perfect for the 501k process. However, the dilemma you mention occurs when you begin to question how similar is this new device compared to device approved 40 years ago? More importantly, the device 40 years ago was approved with severely more relaxed restrictions than a device would undergo today. I believe there are previous products that if were required to undergo the full FDA approval process today would not be able to provide sufficient data to achieve approval. This is definitely an interesting conundrum because the predicate devices that may have not passed FDA approval with todays rules, have proven themselves effective through the patients that have used them for decades.
At first I would have had to agree with your sentiment in that its non sensical to compare a new medical device now to a medical device of 40 years ago for a pre market approval or 510(k). However, after further thought on this subject, I think the reason for that process is because if a device veers too far off of its preceding competitors its going to need a new set of regulation requirements, and rules to abide/adhere to. With how different a device is to its preceding ailment, it can eventually deviate quite far off and be considered as a brand new device because its completely innovated. In short, that whole "similar to a product from 40 years ago" standard is just in accordance to save time and energy of those put in positions to create the new standards or rules, and inspection processes. Yes it seems a little corrupt, but if you think about how overwhelming it'd be for those in the positions of Regulatory Affairs, Quality Assurance, or FDA, they'd get a tsunami or overabundance of new devices flowing onto their approval radar that would take forever to get approved. This is discerning because these products are literally built and designed with the intention of helping people and saving lives.
I can see some of the value of the 510(k). It could make the process more efficient. If a company can prove some similarity to a pre-existing, successful device, then they can use the existing research or data to back up the features of the new device that are similar and subsequently do the required research to prove the safety or efficacy on the improvements being made from the older device. However, I definitely see the confusion with comparing new devices to existing ones. It does not seem to be that beneficial to compare a new device with a much older device when technology has advanced so much and may not be the same.
While I do understand the sentiment that there has been a lot of progress over the course of the years and that 40 years does seem outdated, I still do see a need for it. It is extremely useful if a company wanted to just slightly modify or improve upon a function from an already existing product. This would significantly reduce the time in which that product could make it to the market. However this can allow companies to fast track and perhaps miss vital steps that can result in faulty devices resulting in injuries and death.
The 510(k) clearance can be argued as a both blessing and a curse. Perhaps some modifications should be made such as deeper examination and inspections as well as an increase in self reporting adverse effects. The 510(k) should not be completely thrown out, but rather updated and modified. Are there any updates/modifications that can be made that weren't already listed?
Since 1976, manufacturers have got a chance to get expedited approval from FDA if they can prove their device is similar to a device produced in or before 1976. Eventually, that means we're still comparing with technology that's decades old. Even FDA wants to retire the predicates and to help companies to use advanced technology. In modernizing the process of approval through 510(k), FDA wants companies to use predicates that are not more than 10 years old.
Source: https://www.cnbc.com/2018/11/26/fda-to-overhaul-510k-medical-device-approval-process.html
