Another medical device design engineer here and I second the previous comments that this comment is 100% incorrect. 510k isn't a loophole, shortcut or less sa

Another medical device design engineer here and I second the previous comments that this comment is 100% incorrect. 510k isn't a loophole, shortcut or less safe in any way. Clinical trials are unbelievably expensive, hundreds of millions of dollars or more. Often so much so that they are prohibitively expensive for alternatives to therapies that already exist or for patient populations that aren't large enough to make back the initial investment. Without the 510k pathway much of our modern medical treatment portfolio wouldnt exist as drugs and devices for only the very most lucrative health problems would be cash positive to develop. Thanks to 510k devices thousands of lives are saved every day, and therapies that were once too expensive for the masses can now be afforded.