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    Accreditation Scheme for Conformity Assessment

    FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.

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

    Definition

    Under ASCA, FDA accepts test reports from accredited labs against eligible standards (e.g., portions of IEC 60601-1 and ISO 10993) with a presumption of conformity, reducing the likelihood of additional information requests during review.

    What this means in practice

    Sponsors plan testing with ASCA-accredited labs to compress 510(k) review time on commonly tested standards.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      FDA ASCA
      Bot-blocked
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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