Here’s a former FDA reviewer criticizing the FDA’s handling of the Whoop case! He cites overreliance on precedent and inconsistent policies: “According to the FDA's own language, it's the absence of disease-related claims that determines whether a product is regulated as a medical device. Instead of pursuing low-risk products like this, I believe the FDA should focus on issues that pose greater risks to users and patients, especially in light of the recent resource constraints at the Agency. Priorities, FDA... Priorities.”