On September 23, the Food and Drug Administration (FDA or the Agency) issued its long-awaited final guidance document, Mobile Medical Applications (the Final Guidance), describing how FDA intends to apply its regulatory authority to these software products.
The Final Guidance comes just over two years after the draft version issued in June 2011. Since that time, industry has waited with bated breath for the Agency to provide certainty on its regulatory policy for mobile medical applications or “apps.”