Marc Scheineson moderated this webinar program hosted by the Food and Drug Law Institute (FDLI). The mobile medical application (MMA) industry has grown exponentially in recent years, generating considerable media attention. In an attempt to keep pace, the Food and Drug Administration (FDA) has issued a host of guidances covering topics from wellness products to accessories to medical device data systems (MDDS). While illuminating, this new material has left many questions unanswered. The webinar covered the following topics:
- An overview of the current regulations governing MMAs, paying special attention to the intricacies of the “intended use” doctrine
- Both traditional medical device use cases, as well as pharmaceutical and dietary supplement use cases
- The nature and impact of FDA’s most recent guidance documents on wellness products, device accessories and MDDS
- The approaches FDA and the Federal Trade Commission have taken toward monitoring the advertising and promotion of MMAs
- The future and predictions as to how certain MMAs, like those that provide clinical decision support, are likely to be handled going forward and what impact the FDA Safety and Innovation Act process will have
For more information, please click here.
April 7, 2015