> The first study to point out this problem was from 1991… and yet we didn’t act on it. Well, this information was acted upon, just apparently not with suffici

> The first study to point out this problem was from 1991… and yet we didn’t act on it. Well, this information was acted upon, just apparently not with sufficient vigor. FDA guidance published in 2013 (originally drafted 2007) stated, > Your study should have subjects with a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of your subject pool, whichever is larger. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug https://www.fda.gov/regulatory-information/search-fda-guidan...