I’ve been critical of the FDA in the past. But now that the FDA has released its long-awaited guidance for “Mobile Medical Applications,” I’m pleasantly surprised at the stance the agency has taken. Basically, the FDA has done exactly what it should do–gotten out of the way of innovation, while reserving the right to jump back in if circumstances warrant.
To put it a different way, rather than being annoyingly ambiguous, the FDA has marked a big section of the beach and said “go play in the water, kiddies! Have fun, and we’ll be watching to make sure that no one drowns.” This is the right approach to maximizing both progress and safety. In fact, other regulators should follow the same path.
The issue when it came to mobile medical apps was in some sense simple. Clearly some mobile apps worked just like regulated devices, and therefore needed to come under the same scrutiny. No one disagreed with that. But then there was a whole set of other apps–including ones that provide simple coaching and prompting to diabetics and other people who needed to follow regular schedules–which could have been regulated as medical devices under a strict interpretation of the rules.
But in the guidance, the FDA was extremely clear that it would exercise “enforcement discretion” for these sorts of medical apps. The agency was even kind enough to give a long list of such apps, opening up a clear pathway for innovators. Some examples:
And so forth and so on. You get the idea.
Other regulatory agencies should adopt the same tack. In a world of rapid innovation, regulators cannot and should not engage in pre-emptive regulation. Instead, they should stand back and watch closely, stepping in as necessary. That’s the best way to insure the
