FDA Mobile Medical App Guidance: Implications for the Industry – a Bloomberg BNA Webinar


Bradley Merrill Thompson and Kim Tyrrell-Knott, Members of the Firm, will present "FDA Mobile Medical App Guidance: Implications for the Industry," a Bloomberg BNA webinar.

More than two years after a draft was issued, the U.S. Food and Drug Administration (FDA) recently published its final guidance on mobile medical apps. While the guidance provides much needed clarity for the mHealth industry, many issues remain unresolved and new questions have emerged. This program will focus on answering those questions for app developers in or close to FDA-regulated territory.

The faculty for this program will review the final guidance, discuss what kinds of apps are regulated, which apps are not and which are subject to "enforcement discretion." Practical implications for the industry, including what it really means to be subject to such discretion, will be explored. App developers, investors, medical device and pharmaceutical manufacturers and other industry stakeholders will better understand the regulatory framework and requirements applicable to their products.

Educational Objectives:

  • Understand the scope of the mobile medical app guidance, including what apps the FDA will regulate and what will not be regulated or subject to "enforcement discretion."
  • Learn how to develop mobile apps that come as close to the FDA line as possible, but don't cross over into regulated territory.
  • Discover how the guidance did not address all of the issues for the mHealth industry and what new issues and challenges are being raised for apps that are regulated by the FDA.

For more information, please visit BNA.com.