Mobile Medical App Regulation - Webinar CD/Transcript

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Mobile Medical App Regulation: Impact of FDA’s Evolving Regulatory Policies on Your Technologies

The number of available, mobile medical device apps is growing, with both patients and doctors using the apps.

Although the FDA has expressed concerns regarding the effective use of medical device apps.  The current mHealth strategy leaves developers in limbo. They are not sure what can cause a mobile medical app to receive a warning letter or 483.

Michele Buenafe — partner in the FDA Practice at Morgan, Lewis & Bockius, LLP — will discuss the current regulatory climate for these technologies, regulatory issues that are yet to be resolved, expectations for future developments and the direction of regulatory policy in this space.

The webinar CD and transcript includes analysis of the impact of the following FDA guidance documents on digital health/mobile medical app regulation:

  • Mobile medical apps guidance
  • Draft Guidance, General Wellness: Policy for Low Risk Devices
  • Draft Guidance, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types
  • FDASIA Health IT Report

Ms. Buenafe will also cover anticipated upcoming developments including:

  • Clinical Decision Support Software
  • Potential new legislation

Order today and learn what can cause digital health/mobile medical app products to be either actively regulated or subject to enforcement discretion.

  • Compliance officers
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff

Michele Buenafe is a partner in the FDA Practice at Morgan, Lewis & Bockius, LLP.  Ms. Buenafe regularly advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling and advertising of medical devices, digital health technologies, human tissue products, pharmaceuticals and combination products.  She also advises clients on emerging legal issues relating to mobile medical apps, clinical decision support software, telemedicine systems, wearable devices and other health information technologies.