Regulatory
Third-Party Review of 510(k)(3P 510(k))
In one line
Program in which FDA-accredited third parties conduct the initial 510(k) review for eligible device types.
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.
FDA usually decides within 30 days of receiving the recommendation. Eligible device types are listed on FDA's website, and the review organization charges its own fee in place of the FDA user fee.
Why it matters
Used to compress timelines for well-established product types; not all product codes are eligible.
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.
Sources
- FDA - Medical Devices · FDA
- European Commission - Medical Devices · European Commission
- IMDRF Documents · IMDRF