How is CDRH approaching the whole concept of digital health and the technology and the way that FDA needs to regulate it?

Yeah, so I guess let me take a half step back to try to frame this a little bit for your listeners, and then I'll answer your question.

This really is born out of an effort now a decade old when Congress first put into effect – language through 21st century cures, which defined software as a medical device, because before that time, the agency took the view that any kind of software that touched healthcare, even if it was an electronic health record, was a medical device, and they would choose to exercise enforcement discretion.

Well, after some advocacy from industry the statute clarified what was subject to the FDA's jurisdiction and what was not.

So software is a medical device sort of born as a term of art 10 years ago in 2016.

Under that umbrella, we have things like clinical decision support technology and what's grown out of that sort of tangential also because it was excluded from the FDA's jurisdiction are wellness software that functions as a wellness product.

And so All of these things sort of live under that software as a medical device or digital health umbrella.

But as a practical matter, what kinds of products can consumers expect to see that they can use hopefully safely and effectively by themselves to improve their health? Michael, what do you see coming on the horizon in this area?