It's not just the FDA. The EU's new MDR requires far more scrutiny on the part of the notified body, to the extent that the bodies are mostly deciding not to bother and ducking out of the medical device game.
There is an enormous backlog of things that are almost exclusively approvals of paperwork to demonstrate the process you followed was the process you wrote down.
There is an enormous backlog of things that are almost exclusively approvals of paperwork to demonstrate the process you followed was the process you wrote down.