The FDA puts out a list every year of new documentation and standards for medical devices, food, supplements, cosmetics, pharmaceuticals, etc.
Every year, a company decides that the standards are just draft guidance documents, and therefore optional.
These same companies also cannot understand why their submission is still under review with the FDA ten months later.
These guidance documents serve as the best hard-copy indication of what the FDA is thinking and what they will expect to see in new submissions.
Telling the FDA that they are NOT the boss of you will not work well as a regulatory strategy. It will be much easier – and effective – to align your strategy with the new requirements.