... because 510(k) is a section of the Federal Food, Drug and Cosmetic Act, and as such can only be amended by another Act. FDA may amend the execution of part 510(k) - but not eliminate it.

The 'substantially equivalent' requirement of the 510(k) notification is excellent for 'me-to' medical devices, for which surely the notification method was originally established. On the other hand, the EU system is more clumsy with 'me-to' devices. When it comes to new technologies and new devices the reverse is true. We need to learn from each other.