FDAnews Announces — Mobile Medical App Regulation: Impact of FDA’s Evolving Regulatory Policies on Your Technologies Webinar, April 13, 2016

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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 mobile medical apps, regulatory issues that are yet to be resolved and expectations for future developments and the direction of regulatory policy in this space.

Mobile Medical App Regulation:
Impact of FDA’s Evolving Regulatory Policies on Your Technologies
April 13, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mobilemedicalappregulation    

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 mobile medical apps, regulatory issues that are yet to be resolved and expectations for future developments and the direction of regulatory policy in this space.

The webinar 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  • Draft Guidance, General Wellness: Policy for Low Risk Devices
  • Draft Guidance, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types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

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

Meet the Presenter:
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.

Who Will Benefit:

  • 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

Webinar Details:
Mobile Medical App Regulation:
Impact of FDA’s Evolving Regulatory Policies on Your Technologies
April 13, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mobilemedicalappregulation    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/mobilemedicalappregulation
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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