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FDA Guidance for Industry and FDA Staff: Mobile Medical Applications

by Chad D. Ehrenkranz
Greenberg Traurig, LLP - Washington Office

Nancy E. Taylor
Greenberg Traurig, LLP - Washington Office

November 19, 2013

Previously published on November 15, 2013

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.


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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