I agree with @zw2 that FDA regulations aren’t perfect, but I think the regulations and guideline documents really set the bar to ensure to the best of the its abilities the safety and effectiveness of devices. Sometimes companies follow all the regulations and still something unexpected happens and the product needs to recalled. As we have discussed risk, there needs to be a plan on how to address problems and fix them quickly so that the company still has a profitable business while also ensuring the safety of its customers’.