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    Pivotal Trial

    Definitive clinical study designed to establish safety and effectiveness for marketing authorization.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    A pivotal trial is the primary evidence base for a PMA, De Novo, or PMA Supplement, and increasingly for high-risk MDR submissions. Endpoints are pre-specified, statistical analysis plans are locked, and the study is typically powered for the regulatory hypothesis.

    What this means in practice

    Often preceded by feasibility and EFS studies and followed by post-approval/PMCF studies.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2ISO·1
    1. 1
      FDA IDE Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      ISO 14155 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov

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