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    Class III Device

    FDA's highest-risk device class, generally requiring PMA.

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

    Definition

    Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. They generally require PMA.

    What this means in practice

    Examples include implantable defibrillators and life-supporting devices. Class III devices undergo the most stringent regulatory review.

    Cross-references

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      FDA Device Classification
      Needs review
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.