Mobile Medical Apps Guidance

Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. It is vital for any app developer to understand whether the guidance applies to their product from the initial design stage. Those who are already marketing software and apps that involve healthcare should also review the guidance with care to try to determine how FDA’s new regime impacts both business plans and continuing operations.

The 43-page final guidance is written and organized in a direct and helpful manner. It answers many questions industry had about FDA’s intentions in the mHealth arena, including alleviating a key concern that the agency might regulate the actual mobile platforms upon which apps operate. To assist in understanding the key features of the guidance, we have prepared a summary of the guidance. While the guidance clarifies FDA’s views on many of the issues impacting the mobile medical app world, unanswered questions remain that warrant consideration to ensure the success of an mHealth product. We will address some of those questions in this Alert.

Click here to read this Alert.

Click here to read our summary of the FDA guidance.