4 ms·
How about easier barriers to entry with tougher reporting requirements? I personally fear the FDA is too optimized for bad headline avoidance to the detriment o
by wpasc 7y ago
How about easier barriers to entry with tougher reporting requirements? I personally fear the FDA is too optimized for bad headline avoidance to the detriment of allowing more experimental leeway. Not saying it should be the Wild West, just suggesting that perhaps the risk tolerance is currently too low. What if it were easier to perform more experiments, but if you hid/covered up any bad data there would be hell to pay?
- skwb 7y agoI think the current system is working now, it just needs enforcement. 510(k) applications (where you need a preexisting requisite on class 2, or low/moderate risk device) certainly seem to be doing their job. Lots of healthcare startups (including those using AI algorithms) have used that path to successfully submit to the FDA for clearance. That said, there's a lot of bunk science marketed to consumers within healthcare. Your average consumer heats microbiome and genomics and AI and thinks that the product will cure them of disease. I don't think it's the role for the FDA (until they make specific health claims), but we need to remind consumers to be smart purchases of these services. And for us in the healthcare tech space need to be careful who we want to include within our communities to ensure we share the values of positive patient.