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Software Precertification Model: A Working Model

Software Precertification Program

  • Voluntary pathway to provide more streamlined and efficient regulatory oversight of software as medical devices (SaMD)
  • From manufacturers who have demonstrated a robust culture of quality
    and organizational excellence (CQOE)
  • Committed to monitoring real-world performance

Goals

  • Tailored, pragmatic, least burdensome regulatory oversight
  • Assess – to establish trust of CQOE for high quality SaMD
  • Transparency –  across entire lifecycle of SaMD
  • Verify – continued safety, effectiveness, and performance of SaMD in real world

Outline

  • Excellence Appraisal and Precertification (Component 1)
  • Review Pathway Determination (Component 2)
  • Streamlined Premarket Review Process (Component 3)
  • Real-World Performance (Component 4)

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FDA Announcement related to opioids

FDA supports U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis

  • decreasing exposure to opioids and preventing new addiction
  • supporting treatment of those with opioid use disorder
  • fostering development of novel pain treatment therapies
  • fostering development of opioids more resistant to abuse and misuse
  • taking action against illegal importation and sale of opioids
  • evaluate how marketed opioids are used in both medical and illicit settings and take regulatory action where needed

Action against 53 websites marketing unapproved opioids More information

Patient Focused Drug Development for chronic pain More information

Approval of first generic versions of Suboxone sublingual film More information


Image credit: FDA, DHHS

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