The addition of 510(k) procedure has been a topic of debate for the longest time. From an industry perspective, it is very much vital that a company can use such track to get their product on the Market. A prime example of this would be the flu shot from year to year. Often times a company such as Novartis and Sanofi, will use this procedure to fast track their vaccine into the market in time for the next flu season. This significantly reduces the amount of time that might be needed and allows for the company to change their product to market specifications even if that means changing a very minute detail of their product. In this example, if the next strain of flu is to be made into a vaccine, the company can say that everything in their product is the same, the same reagents, the same diluent, but the only thing that they changed was implemented the latest flu strain to fit their business needs. This fast tracks their regulatory time to a significantly shorter amount of time where as if they had to go through proper legal procedures, it may take well over a year or two to get their product out and in that time the flu strain may have changed.
I think that this is a classic government/bureaucratic loophole because if the Government had done anything differently, there would have been a massive legal issue with every product on the market at the time. Because the US Government had not regulated medical devices since its inception, they had to create a clause that allowed products developed before the beginning of the regulation to be allowed to stay on the market. This clause was necessary, because otherwise, every medical item available at the time would have had to be taken off the shelf and then been subjected to lengthy and expensive clinical trials and regulatory approval only if the results were perfect. This clause was then used to justify improvements on those same devices post the advent of medical device regulations. At this point, it may have been long enough that this clause should be closed, but so many devices have approval because of this loophole that closing it may cause a disastrous domino effect. It is troubling but I am not sure what a regulatory agency could do about it going forward.
This topic brings up an interesting point - even though filing a 510(k) is easier than going the PMA route, and can greatly expedite getting new scientific breakthroughs on the market to treat patients, what are the potential risks of bypassing clinical trials? According to one study by Day et al., when looking at new medical devices released between 2002 to 2012, devices that were cleared using a 510(k) were 11.5 times more likely to be recalled than those cleared with PMA. This is quite alarming, and should definitely be signaling to the FDA that it is time to overhaul the 510(k) clearance process. Technology has developed so rapidly since 1976 that it's hard for me to see how we would still be making new medical devices that are fundamentally similar to those made over 40 years ago.
I think and agree that as technology evolves, the devices will also integrate them and evolve, which is technically for the betterment of humankind. Any device that was considered safe years back would be true, but later there might be some other technology that might work even better, giving less pain and being more time effective. Moreover, the byproduct that one gets later after curing a disease helps a lot with evaluation and acceptance, and it emphasizes that relying on outdated benchmarks can result in outdated safety regulations. At the same time, this also helps in building up a sort of competition with oneself to establish a new benchmark for newer devices, which also minimizes the need for extensive new testing. Hence, I think that considering both concerns—having a benchmark set for its own device or competing with yourself, or evaluating on its own attributes rather than comparing in relation to older models—would help best in facilitating the process and avoiding overcomplication.
Though the 510K process requirement of connecting current devices to those manufactured in 1976 may seem nonsensical, it is important to note that direct comparisons are not always necessary. This means that a chain of similar devices can be compared to each other through the 510K process as long as the chain leads back to 1976. For example, a device manufactured in 1976 could be changed every 10 years and so the 510K compares to the device from 10 years ago each time rather than the original device from 1976. This process makes it much faster and more efficient to get products to the market as many products are new versions of devices that already exist. Evaluating every device from square one would take much longer and ultimately slow innovation in the US. While it is a priority for the FDA to ensure devices are safe, it is also a priority to keep innovation moving steadily.
The 510(k) process can be beneficial and stimulate innovation in many ways. Just because companies may be comparing their device to a device that is 40 years old, if the existing device still works then I do not see an issue with this. The most likely scenario if a company is comparing their device to something that much older is that they are making significant improvements to the technology of the device but serving the same purpose. In order to use the 510(k) approval, the device must be substantially equivalent to an existing device. This means that companies cannot stretch or force their device to fall into the category of 510(k). When it is used correctly, this path saves time and money for companies in getting devices approved and allows the FDA to prioritize spending more time analyzing devices that are completely new to the market or higher risk to patients. This process also allows companies to make minor changes to their devices and adapt to newer technologies without having to go through the same rigorous approval process as they would with a brand-new device. If every minor improvement made to a device had to be evaluated as a completely new device, it would be a drain of resources and discourage companies from continuously improving their products to avoid this tedious process.
