FDA's Low-Risk Device Policy and the Impact on Mobile Medical Device Applications

Duration: 90 Minutes
This webinar will provide the attendees with an overview of both FDA's Low-Risk Device Draft Policy (January 2015) and guidance on Mobile Medical Applications (February 2015), along with insight as to how companies can achieve compliance with both.
Mobile Medical Application Regulation
Instructor: Carolyn Troiano
Product ID: 501520
FDA's existing oversight approach considers functionality instead of platform. Only those mobile applications that are medical devices and have functionality that could pose a risk to a patient's safety if they did not function as intended will be regulated by FDA. FDA refers to this subset of mobile applications as ‘mobile medical applications.'

The attendees will learn what types of mobile medical devices are subject to FDA oversight, the risk they pose to the public if they fail, and how strictly the Agency will enforce its regulations. We will explore the low-risk mobile medical devices over which the FDA has discretionary enforcement. In addition, we will provide an overview of the validation work required for mobile medical devices, similar to what is required for computer systems subject to FDA regulation.

Objectives of the Presentation
  • Gain an understanding of how FDA classifies and regulates mobile medical devices
  • Understand the best practices for ensuring that a mobile medical device is thoroughly tested and validated in compliance with FDA regulations
  • Learn how to develop the appropriate computer validation strategy when dealing with mobile medical applications to ensure a good balance of cost vs. risk
  • Understand how to effectively document the process of computer system validation, and maintain current information about mobile medical applications
  • Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
  • Understand some of the key "pitfalls" to avoid when applying the concepts of computer system validation to mobile applications
  • Understand the industry best practices for implementing and using mobile medical applications, including examples
Why Should you Attend
Some mobile applications do meet the definition of a medical device, but pose a much lower risk to the public. Recognizing this, FDA intends to exercise enforcement discretion over these devices, meaning it will not enforce them. The attendees will learn what types of mobile medical devices are subject to FDA oversight, the risk they pose to the public if they fail, and how strictly the Agency will enforce its regulations.

This webinar is intended for those working in the Medical Device Industry, as well as other FDA-regulated industries, including pharmaceutical, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

Areas Covered
  • Mobile medical applications and classification by FDA
  • Low-risk mobile medical applications and FDA enforcement
  • When and how FDA's general wellness/low-risk guidance should be applied
  • An overview of FDA's regulation of mobile apps
  • What the draft wellness/low-risk guidance means in relation to the draft guidance for mobile applications
  • Comparisons between the draft wellness/low-risk policy and FDA's medical mobile application guidance
  • GxP systems regulated by FDA
  • Computer System Validation (CSV) methodology
  • System Development Life Cycle (SDLC) framework
  • Validation Strategy and Planning
  • System Risk Assessment and Mitigation
  • GAMP 5 System Classification and "V" Model
  • Potential Pitfalls for Implementing and Using Mobile Applications in an FDA-regulated Environment
  • Industry Best Practices for Implementing and Using Mobile Applications in an FDA-regulated Environment
Who can Benefit
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Topic Background
The Food and Drug Administration (FDA) recognizes the extensive variety of medical devices and mobile applications that operate in tandem. The rapid pace of innovation provides both benefits and risks to public health.

As mobile platforms become more user friendly, computationally powerful and readily available, manufacturers have been developing mobile applications of greater complexity to leverage the fact that these devices are portable. Some mobile applications target individuals who require assistance in their own health and wellness management, yet others are for healthcare providers to use as tools to improve and facilitate the delivery of patient care.

The FDA has formally classified certain types of software applications that meet the definition of a device and, through classification, identified specific regulatory requirements that apply to these devices and their manufacturers. These include products that feature one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor cardiac rhythms, as well as devices that are composed solely of software (such as laboratory information management systems).

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Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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