In the case of medical devices, this is squarely in the FDA's wheelhouse in the USA. The FDA likely lacks the people with appropriate expertise to evaluate thes

In the case of medical devices, this is squarely in the FDA's wheelhouse in the USA. The FDA likely lacks the people with appropriate expertise to evaluate these kinds of safety issues because their traditional focus has been on the more typical kinds of medical device risk. A concerted effort at dialog with them could turn that around. Particularly if it were done through a series of academic workshops with key people.