This training on FDA regulation of mobile medical applications is designed to provide attendees with an overview of 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. Attendees will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.
In July 2011, FDA published a draft guidance outlining the small number of mobile apps the agency plans to oversee - those medical apps that could present a risk to patients if the apps don’t work as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.
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applications ('apps') designed for use on smartphones and other mobile computing devices.In July 2011, FDA published a draft guidance outlining the small number of mobile apps the agency plans to oversee - those medical apps that could present a risk to patients if the apps don’t work as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
Course Provider
Karl M. Nobert,
