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Digital Health Software Precertification (Pre-Cert) Program

GOALS

  • Develop tailored and pragmatic regulatory oversight
  • Trust organizations with demonstrated culture of quality and organizational excellence
  • Leverage transparency of organization’s excellence and product performance across entire lifecycle
  • Streamline premarket review to verify the continued safety, effectiveness, and performance

INTENTIONS 

  • Leverage information from all available sources to be more efficient and streamlined without compromising safety and effectiveness
  • Enable modern and tailored approach to allow timely software iterations and changes
  • Ensure high-quality by enabling companies to demonstrate their embedded culture of quality and organizational excellence
  • Learn, adapt, adjust key elements based on program effectiveness

WORKING MODEL

LEARN


Image credit: FDA

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