FDA says relax: light touch regulation of mobile apps won’t stifle innovation

22 March 2013 |

In testimony before the US House Energy and Commerce Committee, FDA ODE Director Christy Foreman argues that FDA’s narrowly targeted “Enforcement discretion” will mean regulation only of limited subset of Apps.

Challenged that FDA regulation of Apps will stifle innovation, Foreman pointed out that draft guidance from FDA has made it clear that the Agency will continue to target only a narrow set of Apps which either:

  1. can be used as an accessory to a regulated medical device,or
  2. transform a mobile platform into a regulated medical device.

Foreman also re-iterated “FDA’s proposed mobile medical apps policy would not regulate the sale or general consumer use of smartphones or tablets.”

The simple message – relax, FDA isn’t about to mess with your iPad or Smartphone, but will only regulate apps which have significant medical device features and present real patient risks.


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