§360k State and local requirements respecting devices

Summary

States and local governments may not make or keep rules about devices meant for people if those rules are different from or add to federal rules when they deal with safety, how well the device works, or any other topic the federal rules already cover. A state can ask the Secretary to allow its rule. The Secretary can approve it after notice and an oral hearing if the state rule is stricter than the federal rule, or it is needed because of serious local conditions and following it would not make the device break federal law.