I'm willing to accept to a large amount of honest disagreement of how much regulation is appropriate for medical technology. But articles like this, which twist

I'm willing to accept to a large amount of honest disagreement of how much regulation is appropriate for medical technology. But articles like this, which twist the truth and drop so much context make my blood boil. Some examples: "Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials)" This is only true if the medical device in question is an update to an existing medical device that has extensive clinical data and use in the field. Sometimes that minor update is as minor as a software modification. "And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence" This is true because it's unethical to conduct major surgery on someone to give them a placebo, so we can't really blind the studies. They are definitely randomized and controlled though. "In fact, according to a 2014 journal article co-written by one of us, the F.D.A. has never issued a warning letter or penalty for a postmarket study delay." This is laughably untrue. I've in fact worked for two companies that received penalties for not being timely in postmarket surveillance. It might be true that FDA has never given a warning letter (which is their version of 'you've been a bad boy, no new products for you until you get your shit together) solely for postmarket reporting failures, but that's a much different claim. "When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses)." Wingspan was left on the market because for certain classes of patients it was a good treatment. FDA's action was appropriate. "But alarmingly, the 21st Century Cures Act would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices." This is the mechanism that Europe uses to approve all medical devices, not just changes, and it is not the nightmare scenario the authors make it out to be. The reason is that the regulatory middlemen have balanced incentives: they can't be too lax because when they get audited by the European Commission they can lose their license (and in effect go out of business). They can't be too strict because a manufacturer has 5 other companies they can do business with.