--- title: "3P 510(k), Third-Party Review of 510(k) | MedTech Terms" description: "Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types. Plain-English Regulatory definition for MedTech teams" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/third-party-510k#term", "name": "Third-Party Review of 510(k)", "alternateName": "3P 510(k)", "description": "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. 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The third-party organization provides a recommendation, but the FDA still conducts a final administrative review and issues the clearance letter." } }, { "@type": "Question", "name": "What are the benefits of using a Third-Party Review Organization?", "acceptedAnswer": { "@type": "Answer", "text": "The primary benefit is the potential for reduced review times compared to direct FDA review, especially for straightforward devices, as well as accessing specialized expertise from the third-party reviewer." } }, { "@type": "Question", "name": "Are all Third-Party Review Organizations the same?", "acceptedAnswer": { "@type": "Answer", "text": "No, while all are FDA-accredited, they may have different areas of expertise or specific product codes they are authorized to review. Manufacturers should select an organization appropriate for their device." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Third-Party Review of 510(k) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)3P 510(k) # 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 Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Eligible Class I and Class II device [510(k)](/terms/510k)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 What types of devices are eligible for third-party 510(k) review? 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. Does third-party review replace the FDA's role in 510(k) clearance? What are the benefits of using a Third-Party Review Organization? Are all Third-Party Review Organizations the same? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) ### More in Regulatory · Same category [ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca)[ Regulatory Additional Condition for Nonprescription Use(ACNU) FDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider. ](/terms/acnu) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 IMDRF· 1 1. [1 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym 3P 510(k) Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=third-party-510k) Learn in 60 seconds Card Lesson Quiz Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types. - · Used to compress timelines for well-established product types; not all product codes are eligible. - · Final clearance still rests with FDA. Remember this Watch out: 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. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Abbreviated 510(k) ](/terms/abbreviated-510k) You may also need Auto-suggested from Regulatory and shared keywords. - [Accreditation Scheme for Conformity Assessment(ASCA) ](/terms/asca) - [PMA Supplement Types ](/terms/pma-supplement-types) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [Premarket Approval(PMA) ](/terms/pma) - [Refuse to Accept(RTA) ](/terms/rta) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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