FDA’s “Mobile Medical Apps” Guidance: What’s In? What’s Out?

By Julie Tibbets posted 27-Sep-2013 15:28

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This week, the U.S. Food and Drug Administration (FDA) released its Final Guidance on Mobile Medical Applications, which revamps the agency’s Draft Guidance and evidences careful review and consideration of the 130 stakeholder comments it received on its Draft Guidance. The long-awaited Mobile Medical App Final Guidance may signify a win for industry, as FDA’s decision to regulate only a small portion of mobile apps—“mobile medical applications”—made by mobile app developers fitting the definition of a “mobile medical app manufacturer” appears to represent an even more hands-off approach than what was initially suggested in the 2011 Draft Guidance. This is good news for companies making mobile platforms themselves, as well as Internet providers and third parties that offer mobile medical apps for sale, but that are not involved in the design, development or manufacturing of those apps. This is also good news for makers and marketers of FDA-regulated products in both the drug and device areas that have been reluctant to forge ahead in the software space on patient tools in their direct-to-consumer (DTC) offerings, since educational patient tools are generally exempted or given enforcement discretion.

For takeaways, open questions remaining, and what the Final Guidance ultimately means for stakeholders, read my full article here: http://www.alston.com/files/publication/0115ae79-5994-4b9d-af87-15c1346f8e83/presentation/publicationattachment/366b44ff-e0b3-43d3-aeed-1984b5acc804/13-739%20mobile%20medical%20apps.pdf.

Julie Tibbets is a partner in the Food, Drug & Device/FDA Practice of Alston & Bird LLP where she focuses her practice on advising manufacturers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related matters and interactions. This publication is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions. Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.

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