On-label, off-label, and who is allowed to say what
A physician and a manufacturer are governed by different rules, which is why they can say different things about the same device.
Two different sets of rules
The FDA regulates devices and how manufacturers promote them. It does not regulate the practice of medicine. Those are separate, and the distinction explains most of the confusion in this category.
What a physician may do
A licensed practitioner may generally use a legally marketed device for a use outside its cleared indication, where that judgment is made in the interest of the patient and is grounded in sound medical evidence. This is ordinary medicine, not a grey area. Professional obligations still apply, including informed consent and the standard of care.
What a manufacturer may not do
A manufacturer is generally restricted from promoting uses beyond the cleared indication. Advertising, sales conversations, booth materials and rep training all sit inside that boundary. This is why a rep can be asked a direct clinical question and answer it only partially, and why a company that answers it fully in writing takes on real risk.
Where an independent board sits
A practising physician describing their own clinical experience is speaking for themselves, in their own name, under their own professional obligations. That is a different act from a manufacturer making a claim, and it is the act this platform is built to carry and attribute clearly.
The separation only holds if it is real. Content a company pays for and content a board authors are kept apart and labelled, so a provider always knows which one they are reading.
General information for medical professionals, not legal or medical advice. Regulatory status varies by product and changes over time. Verify a specific device against its own clearance record before relying on anything here.