This is my message to those who are fearful of changes to the regulatory state with the FDA. Please keep your head about you. The way rules promulgate take time and are codified in law. From there it is your job to bring attention through the public hearings and comment periods what it would do to public health and safety. Your comments are on the record and are the breadcrumbs for the lawyers will feast on it. They may siphon off money but they and then pressure from insurance companies will put pressure on requirements.
If for some reason those are thrown out the window, and that would be a big if (like huge), then run your quality management system to the letter. You are responsible for it. That is enshrined in the CFRs.
The regulatory state may change but lawfare will not change. The only way this breaks is if lawyers stop suing companies for bad actions. That means every decision is on the record. If legal accountability is thrown out the window, then we have bigger problems.
Stack up your objective evidence. Show the value of guidance and that it keeps the wheels turning.
If the regulatory landscape changes overall be assured that the rest of the world has not. For drugs and devices, the rest of world would likely preclude import without the the critical objective evidence.
Stay in the game. Remember the good actors that surround you. If you work for a company that has no boundaries then that is a different category of problem all together and that problem exists right now. Integrity is key.
You are the person standing responsible for public health. Do. Your. Fing. Job.
There may be stupidity afoot. There may be things that you agree with. But remember the patients and the public. You will have to look your family in the eye and yourself in the mirror.
Good luck.
PS: if there is a law that codifies preemption for FDA clearances then I reserve my right to add some new responsibilities.