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    Third-Party Review of 510(k)

    Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types.

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

    Definition

    Eligible Class I and Class II device 510(k)s can be reviewed by an FDA-accredited Third Party Review Organization, which submits a recommendation to FDA. Final clearance still rests with FDA.

    What this means in practice

    Used to compress timelines for well-established product types; not all product codes are eligible.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      FDA Third Party Review
      Bot-blocked
      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.