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

Event Detail

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.