Mobile medical applications – draft guidance – FDA – 21 July 2011

Posted on July 20, 2011. Filed under: Health Informatics, Health Technology Assessment | Tags: |

Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications – 21 July 2011

This guidance document is being distributed for comment purposes only.

Extract from the introduction

“The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”).

Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or “mobile medical apps.” ”  … continues

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