Yes, these are what are known as "pre-amendment" devices, referring to those types of devices that were legally marketed in the US prior to the 1976 amendment to the FD&C Act that gave FDA power to regulate medical devices. FDA was given power to require these devices require PMAs via rulemaking, and has been slowly (far too slowly, in the views of many) closing this loophole.

Yes. FDA 100% cares if your device works as well. "Works as well as the predicate" is the foundation of the substantial equivalence paradigm that underlies the 510(k) process.

Better is a different story. Legally, they _can't_ care (in a 510(k) anyway), if it works better or not.

And had your management not backed down, and tried to push this through as a Letter to File, you'd have been well-within your rights to blow the whistle to FDA. There's not a FDA employee alive that wouldn't go "hold on there chief" to a device change of this magnitude.

It’s a very bold statement to say when you have no evidence that Boom would or even could ship an airplane that would put people’s lives in danger.

Theranos was not simply a company that made large promises that required leaps in technology and then lied repeatedly about having succeeded in making those leaps. They risked patient safety by providing phony blood test results. It’s important not throw around that epithet unless it’s earned.