Should the FDA even be reviewing mobile apps? Or go out for a walk?

Donna Cusano

The FDA has provided its draft guidance for select mobile apps [TA 26 July and 21 July]…but do they even have the ‘bandwidth’ to cover what falls under their regulation in a timely fashion? This article in Hospital Impact proposes that FDA cannot, citing its giving up on social media regulation by pharma, and needs to look at a different model. FDA lacks bandwidth to evaluate mobile health apps. (And a suave hat tip to reader Trevor Cradduck.)