• FDA Guidance for Industry and FDA Staff: Mobile Medical Applications
  • November 19, 2013 | Authors: Chad D. Ehrenkranz; Nancy E. Taylor
  • Law Firm: Greenberg Traurig, LLP - Washington Office
  • On September 25, 2013, the Food and Drug Administration (the "FDA") released final guidance on the regulatory requirements regarding the introduction of mobile medical applications into the marketplace (the "Final Guidance"). The purpose of the Final Guidance and its Appendices is to assist manufacturers with determining if a product is a mobile medical app and if so the FDA’s expectations for that product. This Alert summarizes some the key components of the Final Guidance.