[SentinelLdnma]

Hardware came from oversees and there was no licensed PE on the US side. But you're right, there should have been.

This was before the device was submitted to the FDA for approval. Chance they would have rejected it. A fallback position for a developer not willing to Play It Hard would be to make sure the risk docs submitted to FDA document this failure path. There is a whole process you are supposed to go through to analyze risks / harms and whether your controls are adequate.