One of the critiques the IOM said about the 510 (K) process was that it lacked the legal basis to be reliable of the safety and effectiveness of moderate -risk class II devices. The reason why the 510(K) lack safety and effectiveness is because of its reliance on “substantial equivalence”. The IOM believes that relying on the substantial equivalence cannot guarantee that devices reaching the market are safe and effective. In fact, the majority of these substantially equivalent devices never go through review for safety or effectiveness. Thereby, the IOM are implying that the 510(K) does not determine if a device is safe or effective. I feel like this is a good point the IOM made about the substantial equivalent products. For instance, I can develop an LVAD that has “substantial equivalence” to the older LVADs, but who is there to check if the LVAD that I developed is indeed safe and effective. Thus, IOM does make a good argument to ensure 510(k) can determine a device as safe or effective.
Thus, the IOM proposes to develop a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide the assurance of this safety and effectiveness of Class II device that the 510(k) previously lacked. This new process would allow devices to the reach the market in aa rapid and least burdensome manner. I believe this suggestion is a good idea. The reason is that the FDA approval of medical devices is long as it is, especially for class III devices. Companies can get approval for the device aboard to avoid these regulations. Thus, causing an issue when the product is on market in the USA. Therefore, this new framework can allow the FDA approval process to be little fast and ensure companies are not getting approval aboard.