7 Takeaways From FDA's Mobile Medical Apps Guidance

Law360, New York (September 24, 2013, 6:57 PM ET) -- The U.S. Food and Drug Administration's release this week of final guidance on mobile medical apps provides much-needed clarity, yet it also leaves big questions unanswered and signals that ramped-up enforcement awaits, experts say. Here, attorneys share with Law360 their seven biggest takeaways.

App Makers Can't Plead Ignorance any Longer

In discussing Monday’s guidance, FDA officials emphasized the vast number of apps they are shielding from oversight, either because they aren’t technically medical devices or because they’re not very risky. But equally important is that the FDA...
To view the full article, take a free trial now.
Try Law360 for free for seven days
Already a subscriber? Click here to login

Already have access?

  1. Forgot your password?
  2. Sign In

Get instant access to the one-stop news source for business lawyers

Required