FDA Third Party Review Program: 510(k) Due Diligence Checklist

What This Article Covers / Does Not Cover

This article covers one decision: whether to use the FDA Third Party Review Program (3P510k, formally the Accredited Persons Program) for your 510(k) submission, and how to perform the due diligence needed to make that decision confidently. It provides a step-by-step eligibility check, a vendor-selection checklist, a conflict-of-interest screening protocol, timeline and cost analysis, and a decision framework for when to use — and when to avoid — third-party review.

This article does not cover how to write a 510(k) submission, how to select a predicate device, or how to prepare an eSTAR package. For 510(k) fundamentals, see 510(k) Submission Guide. For eSTAR preparation, see FDA eSTAR Electronic Submission Template. For cost analysis, see How Much Does a 510(k) Cost.

Program Overview

The 510(k) Third Party Review Program was created by the FDA Modernization Act of 1997 (FDAMA) and codified under Section 523 of the FD&C Act. Under this voluntary program, FDA-accredited Third Party Review Organizations (3P510k Review Organizations, formerly called Accredited Persons) conduct the primary review of 510(k) submissions for eligible low-to-moderate risk devices. FDA then makes the final clearance decision within approximately 30 days of receiving the third party's recommendation.

Key program characteristics:

• Voluntary: manufacturers choose whether to use the program

• No FDA user fee: the only payment is between the sponsor and the 3P510k Review Organization; there is no separate MDUFA fee to FDA

• Approximately half of all 510(k) device types are eligible

• FDA retains final decision authority and may request additional information or re-review the submission

FDA issued final guidance in November 2024: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review, which supersedes all prior guidance on the program.

Step 1 — Verify Product-Code Eligibility

Eligibility Check Process

START:
Q1: Is your device Class I or Class II?
    ├── Class III → NOT ELIGIBLE (use Traditional 510(k) or PMA)
    └── Class I or II → Q2

Q2: Is the device permanently implantable?
    ├── YES → NOT ELIGIBLE
    └── NO → Q3

Q3: Is the device life-sustaining or life-supporting?
    ├── YES → NOT ELIGIBLE
    └── NO → Q4

Q4: Look up your product code on FDA's List of Devices
    for Third Party Review
    (accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/current.cfm)
    ├── Product code is listed → ELIGIBLE
    └── Product code is NOT listed → NOT ELIGIBLE

Q5 (if eligible): Is at least one accredited 3P510k RO
    authorized to review your product code?
    ├── YES → PROCEED TO DUE DILIGENCE
    └── NO → Cannot use program (no reviewer available)

Product-Code Eligibility Lookup

Common Eligible and Ineligible Device Examples

Step 2 — Evaluate Timeline and Cost Tradeoffs

Timeline Comparison

Cost Comparison

Cost-Benefit Decision Matrix

Step 3 — Select and Vet an Accredited 3P510k Review Organization

Current Recognized Review Organizations (as of April 2026)

FDA maintains the current list at accessdata.fda.gov. The following organizations were recognized as of the latest update:

Important: Check FDA's current list before engaging any reviewer. Organizations can lose accreditation (e.g., ADAS lost recognition as of August 13, 2021).

Vendor Selection Checklist

Performance Metrics to Review

FDA publishes quarterly performance reports for each 3P510k Review Organization with at least five completed submissions. Key metrics:

Step 4 — Conflict-of-Interest Screening

FDA's November 2024 final guidance emphasizes conflict prevention and integrity requirements for 3P510k Review Organizations. Sponsors should also conduct their own COI screening.

Conflict-of-Interest Checklist

COI Attestation Template (Illustrative)

[Review Organization Name] confirms that:

1. We have not provided consulting, design, development, or testing services for [Device Name / 510(k) Number] or the manufacturer [Company Name].

2. We are not affiliated with any competitor manufacturer of [Device Type].

3. We have no financial interest in [Company Name] or [Device Name].

4. We have not reviewed a 510(k) submission for a direct competitor device within the past 12 months for the assigned review team.

5. We will notify the sponsor immediately if any conflict arises during the review.

Step 5 — Understand FDA's Final-Determination Risk

How FDA Handles the RO Recommendation

Risk Mitigation Strategies

Step 6 — eSTAR and Third Party Review Interaction

Submission Workflow

Sponsor prepares eSTAR package
        │
        ├── Verify RTA checklist completeness
        │
        ├── Submit to 3P510k Review Organization
        │     ├── RO conducts primary review
        │     ├── RO may issue AI requests
        │     ├── Sponsor responds to RO AI
        │     ├── RO completes review and prepares recommendation
        │     └── RO forwards recommendation + full submission to FDA
        │
        └── FDA receives package
              ├── FDA reviews RO recommendation
              ├── FDA may issue its own AI request (30-day window)
              ├── FDA makes final SE/NSE decision
              └── FDA informs RO; RO informs sponsor

eSTAR Considerations for 3P510k

When NOT to Use Third Party Review

Common Failure Modes and How to Remediate

What Goes in the File

Document Index

RACI for 3P510k Decision and Execution

Key Regulatory References

Due-Diligence Checklist: Complete Pre-Engagement Review

Eligibility

• Device is Class I or Class II

• Device is not permanently implantable

• Device is not life-sustaining or life-supporting

• Product code appears on FDA's List of Devices for Third Party Review

• At least one accredited 3P510k RO is authorized for the product code

Review Organization Selection

• RO is currently recognized by FDA (verified on current list)

• RO is authorized for the specific product code

• RO has experience with the device type

• RO performance metrics are acceptable (NSE rate, hold rate, time to SE)

• Fee quote obtained and competitive

• Written timeline commitment received

Conflict of Interest

• RO has not provided consulting for the device design, development, or testing

• RO is not affiliated with a competitor

• RO has no financial interest in the device or manufacturer

• RO has provided written COI attestation

• No RO team member was recently employed by sponsor (or disclosed and evaluated)

Risk Assessment

• Device does not have novel technological characteristics requiring FDA specialized review

• Device does not require clinical data (or RO has clinical review capability)

• No prior FDA AI history for the same device that would benefit from FDA familiarity

• No Breakthrough or STeP designation that provides better FDA interaction

Contract and Process

• IP protection and confidentiality clauses reviewed by legal

• Accreditation status warranty included in contract

• AI request handling process documented

• Communication protocol and response times agreed

• Payment terms clear (milestone-based or upon completion)

• Exit clause defined (if RO loses accreditation or sponsor wishes to withdraw)

Submission Readiness

• eSTAR package complete and RTA checklist verified

• Cover letter identifies submission as Third Party Review 510(k)

• All testing data included and formatted per FDA expectations

• Predicate device summary clearly presented

• Response package for potential FDA AI prepared in advance