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Broadcast time: 1 hour 30 minutes
The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and it focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.
This webinar will explore that final guidance, teasing apart exactly what types of apps in the pharmaceutical space will be regulated and which ones will not. Presenters will explore several pre-prepared case studies that focus squarely on the difficult issues associated with applying that guidance to the pharmaceutical use cases. Three commentators will provocatively discuss the different possible interpretations of the guidance as applied to the case studies, and then we will ask the attendees to put the technology at issue into one of the following four categories:
1. Unregulated mobile app
2. FDA regulated drug labeling
3. FDA regulated medical device
4. FDA regulated medical device constituent part of a combination product
Who should attend?
- Drug Development and R&D Professionals
- Pharmaceutical and Medical Device and Diagnostics Professionals
- Regulatory, Clinical and Other Professionals Responsible for Developing Drug/Device Combinations and Companion Diagnostics
- Regulatory Affairs Professionals
At the conclusion of this webinar, participants should be able to:
- Discuss the FDA Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff
- Identify what types of apps in the pharmaceutical space will be regulated and which ones will not