FDAs Oversight of Mobile Medical Applications (apps) for Use on Smartphones and Similar Mobile Devic (Medical Device)
Venue: Online Event
|Event Date/Time: Mar 28, 2012||End Date/Time: Mar 28, 2012|
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 Administrationâ€™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In July 2011, FDA published a draft guidance outlining the small number of mobile apps the agency plans to overseeâ€”those medical apps that could present a risk to patients if the apps donâ€™t work as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 FDAâ€™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.
- Gain a basic understanding of FDAâ€™s regulatory oversight of mobile medical apps.
- Provide attendees with an overview of the meaning of FDAâ€™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 FDAâ€™s regulation of mobile medicals apps.
- Offer strategies for marketing a regulated app.
- Describe the types of data needed to support FDA clearance.