Hi, author here! I totally agree there's a cost-benefit tradeoff to be made. I think the 510k process seems appropriate for low-risk devices like latex gloves a

Hi, author here! I totally agree there's a cost-benefit tradeoff to be made. I think the 510k process seems appropriate for low-risk devices like latex gloves and bandages. My concern is mostly around the class II devices cleared through this process, such as the recently recalled Philips CPAP machines, which resulted in 561 deaths. [1] Philips also knew about complaints without informing the FDA. [2] [1]: https://www.cbsnews.com/news/fda-sleep-apnea-philips-recall-cpap/ https://www.cbsnews.com/news/fda-sleep-apnea-philips-recall-... [2]: https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared https://www.propublica.org/article/philips-kept-warnings-abo...