It's important to state that we do not want to create less of a safety or evidentiary standard. It may be that you do the same amount of work. It's just that we don't have old regulations from the 1960s governing, for example, a drug that's very advanced. We're seeing right now, for example, in artificial intelligence there is a rule in the medical device regulations that says every time you make a significant change you have to revalidate the software. For artificial intelligence, you would be constantly doing this.
It would be tailoring the requirements. It wouldn't be lifting away any safety requirements. It would be saying, for artificial intelligence, which hospitals are using now very beneficially, “This is something that's an advanced technology product. We're not going to make you revalidate. Here's the thing that we will do: We will look at your quality control system.”
It's doing that without having to make a regulation for a whole number of years. It's not lowering the bar or making it easier or harder. It's actually tailoring the requirement.
We do share those concerns. That's why we regimented the schedule and we're making sure that we would have the safety requirements well in order.