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reshamn replied to the topic Discussion Topic: Revamping the 510(k) Process in the forum Regulatory Basics for Medical Devices 8 years, 2 months ago
The FDA is continuously improving its 510k process to keep themselves aligned with the evolving technology and new devices. However, the Institute of Medicine report points out that the existing process was never meant to screen out the inefficacy in products. The biggest issue at hand is that the existing process only requires the companies to show previous similar products that are safe. This way the companies are just sort of parlaying on without the examination of safety on those products. The process is not completely ineffective but rather needs to be amended with changing times. However, this is is a tedious process as this will only increase lobbying for proposals or amendments in the congress. Meanwhile, the FDA could tighten its grip on tracking the class 2 devices that are already on the market to mitigate it. The FDA needs to invest in resources for designing or enhancing the integrated premarket and postmarket regulations whether it is to create a new committee that will deal with the amendments or coming up with more documentation that covers up the flaws and requires more information and accountability from the companies with the existing 510k documents.