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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 the regulation says
    The FDA Modernization Act of 1997 authorized the third-party review program for 510(k) submissions, as outlined in FDA guidance documents like "Guidance for Industry and FDA Staff Third Party Review Programs" (2018). This program allows accredited third parties to conduct the primary review of certain low-to-moderate risk medical devices, aiming to expedite the regulatory process while the FDA retains final clearance authority. The scope and eligibility criteria for devices are specified by the FDA, with only a subset of Class I and Class II devices qualifying.

    What this means in practice

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

    Examples

    • A manufacturer of a new, conventional blood glucose meter opts for third-party review to potentially accelerate its 510(k) clearance process.
    • A company developing a surgical tool with a well-established predicate device chooses a Third-Party Review Organization to handle the initial technical review of their 510(k) submission.
    • A medical device startup with limited internal regulatory resources uses a third-party reviewer to leverage their expertise and streamline the 510(k) submission for a Class II diagnostic imaging accessory.
    Common pitfalls
    • •A common pitfall is submitting an eligible 510(k) to a Third-Party Review Organization without ensuring the device falls within the specific product codes and limitations accepted by that particular organization.
    • •Another mistake is assuming that third-party review guarantees faster clearance, as the FDA still performs an administrative review and can request additional information, impacting the overall timeline.
    • •Companies sometimes fail to perform due diligence on the accreditation and experience of a Third-Party Review Organization, potentially leading to incomplete reviews or delays.
    • •Misunderstanding that the third-party reviewer acts on behalf of the manufacturer, not as a representative of the FDA, can lead to compliance issues.
    • •Failing to prepare the 510(k) submission to the same standard as a direct FDA submission is a pitfall, as third-party reviewers adhere to FDA requirements and expectations.

    Frequently asked questions

    Generally, certain Class I and Class II devices that are well-understood and have established predicate devices are eligible, as defined by FDA product codes and program guidance documents.
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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·1European Commission·1IMDRF·1
    1. 1
      FDA - Medical Devices
      Verified
      FDAfda.gov
    2. 2
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

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