[seren]

As someone working on Class III medical devices, it is true that the FDA does not check if your design is "safe", only that the documentation and process seems to have been followed, but on the other hand you are also required to monitor your install base and report any hazardous event, and in case no adequate remediation/plan to your adverse events, they have the real power to stop the commercialization of the product.

But I agree this is coming a bit late in the process if people have already been harmed.