FDA's Oversight of Mobile Medical Applications (''apps'') for Use on Smartphones and Similar Mobile Devices

Why Should You Attend:

Today, mobile medical apps are used for a variety of reasons that include helping consumers manage their own health and wellness, and helping health care providers improve and facilitate patient care. This webinar is designed to provide attendees with an introduction to the U.S. Food and Drug Administration’s oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices.

In July 2011, FDA published a draft guidance outlining the small number of mobile apps the agency plans to oversee—those medical apps that could present a risk to patients if the apps don’t work as intended. In the published guidance document, FDA proposed to oversee mobile medical apps that are (1) used as an accessory to an FDA-regulated medical device, and (2) transform a mobile platform into a regulated medical device. This webinar will provide an overview of FDA’s regulation of mobile medical apps, and help attendees distinguish between those apps requiring FDA review and those not subject to regulatory oversight. Additionally, it will clarify the regulatory responsibilities of those who manufacture regulated apps.

Learning Objectives:

• Gain a basic understanding of FDA’s regulatory oversight of mobile medical apps.
• Provide attendees with an overview of the meaning of FDA’s July 2011 guidance document.
• Describe the criteria used to distinguish between regulated and unregulated app.
• Provide examples of the types of mobile medical apps that FDA intends to regulate.
• Summarize FDA’s regulation of mobile medicals apps.
• Offer strategies for marketing a regulated app.
• Describe the types of data needed to support FDA clearance.

Areas Covered in the Webinar:

• FDA’s regulation of mobile medical apps.
• The criteria for distinguishing between regulated and unregulated mobile medical apps.
• Discussion of the responsibilities of a regulated entity.
• The July 2011 Mobile Medical App Draft Guidance Document.
• What regulatory requirements must a manufacture comply with to market a regulated app.
• Identification of application FDA regulations, guidance documents and other relevant documents .

Who Will Benefit:

• Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists.
• Medical device and Biotech Companies, Start-ups, Foreign Device Manufacturers, Importers, Device Reprocessors; Mobile and Smartphone Companies; the Telecom Industry
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

Topic Background:

In a July 19, 2011 press release, FDA announced its intent to regulate only a small subset of mobile medical apps that impact or have the potential to impact the performance or functionality of currently regulated medical devices. As further described in that announcement, such apps include (1) apps that are used as an accessory to a medical device already regulated by the FDA (i.e., an app that allows a physician to make a diagnosis based on an image retrieved from a cloud by a smartphone or tablet); and (2) apps that transform a smartphone or tablet into a regulated medical device by using attachments, sensors or other devices (i.e., an app that turns a smartphone into an ECG machine).

The July 2011 guidance document focused on several different issues. First, it defined three key terms: Mobile Platform, Mobile Application and Mobile Medical Application. Second, it confirmed FDA’s intent to determine whether a product is a mobile medical app based on its intended use, and discussed the categories of mobile medical apps that it intended to regulate. These included mobile apps that act as accessories to regulated medical devices, and mobile apps that transform a mobile platform into a medical device. It also provided additional examples of mobile medical apps. Third, the draft guidance identified categories of mobile apps that FDA did not intend to regulate. Finally, the draft guidance document discussed the responsibilities of regulated entities and the requirements for regulatory compliance.

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