Regulating Digital Health Tools: Understanding the FDA’s New Guidances

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Regulating Digital Health Tools
Understanding the FDA’s New Guidances

Clinical decision support software … software as a medical device … artificial intelligence and machine learning – rapid developments in digital technology are blurring the line between FDA-regulated medical devices and unregulated “lifestyle apps.”

To keep pace, the FDA has issued a slew of guidances to explain what and how it will regulate software-driven devices. The final guidance Software as a Medical Device and two draft guidances, Clinical and Patient Decision Support Software and Multiple Function Device Products, aim to clear up the confusion, but devicemakers still need a map for navigating the regulatory maze.

Regulating Digital Health Tools — based on a presentation by noted regulatory expert Bradley Merrill Thompson — combs through the guidances and sets out the rules devicemakers must follow. You’ll learn:

  • How the FDA’s new policy allows sponsors to comply with postmarket surveillance requirements
  • How the FDA is working with industry to promote innovation in the development of digital health functions, as well as how these novel products can be integrated into advanced therapeutic options for patients
  • The status of the FDA’s precertification pilot program and how it may determine future regulation
  • Industry reaction to the FDA’s efforts

Regulating Digital Health Tools: Understanding the FDA’s New Guidances gives readers a complete understanding of how the FDA is regulating software applications and digital health devices — and where a device falls on the spectrum from unregulated “lifestyle” apps to high-risk regulated medical devices.

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Table of Contents

  • Introduction
  • The FDA’s New Mobile App Policies
  • Enforcement Discretion: Regulated v. Unregulated
  • Predicting FDA Behavior
  • And More …

View the entire TOC

Who Will Benefit

  • QA/QR/QC
  • Regulatory affairs
  • Compliance affairs
  • Strategic planning
  • R&D

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