FDA Third-Party Review (3P510k): The Overlooked Route to Faster 510(k) Clearance (Complete Guide)
- Beng Ee Lim
- Oct 21
- 7 min read
Updated: Oct 24
The FDA’s 510(k) Third-Party Review Program (3P510k) is a voluntary alternative pathway allowing accredited organizations to review certain eligible Class I and II medical devices instead of FDA performing the full review.Third-party reviewers forward their technical recommendation to FDA, which aims to issue a final clearance decision within about 30 calendar days of receiving the complete review package.
By using the 3P510k route, you avoid paying FDA user fees, though Review Organizations charge their own fees. The process can help accelerate review timelines for straightforward, well-understood devices.
This complete guide explains how the 3P510k program works, which devices qualify, and when choosing this lesser-known pathway could speed up your FDA clearance and market entry.
What Is FDA's Third-Party Review Program?
The 510(k) Third Party Review Program allows FDA-accredited Review Organizations to conduct the initial technical review of eligible 510(k) submissions instead of FDA staff performing the review.
Here's how it differs from traditional 510(k) review:
Traditional 510(k) Process:
Submit to FDA → FDA reviews → FDA requests additional information → You respond → FDA makes clearance decision
Timeline: 90 days (often 120-180 with questions)
User Fee (FY 2025): $6,517 (small business) or $26,067 (standard)
Third-Party Review Process:
Submit to accredited Review Organization → Third-party reviews → Third-party requests additional information → You respond → Third-party forwards recommendation to FDA → FDA makes final decision within ~30 days
Timeline: Variable third-party review + guaranteed 30-day FDA decision
User Fee: $0 to FDA (you pay Review Organization directly)
Critical Point: FDA still makes the final clearance decision. Third-party reviewers conduct the technical review and forward their recommendation, but FDA retains ultimate authority.
The Numbers That Make This Compelling
Cost Savings
You eliminate FDA user fees entirely:
Small Business: $6,517
Standard Company: $26,067
Instead of paying these to FDA, you pay a Third-Party Review Organization (RO) directly — typically $10,000–$25,000, depending on device complexity.
Even at the higher end, standard companies can still save $5,000–$15,000+ in fees alone while gaining faster access to FDA’s final decision.
Timeline Benefits
Once your accredited reviewer completes the evaluation and forwards it to FDA, the agency targets a 30-day review window for final clearance decisions.
In contrast, traditional 510(k) reviews can stretch 120–180 calendar days, particularly when Additional Information (AI) requests pause the review clock.
For experienced teams with well-characterized devices, the 3P510k path can accelerate time-to-market by several months.
FDA Resource Focus
By shifting routine 510(k) reviews to accredited Review Organizations, the FDA can focus its internal resources on higher-risk and innovative technologies — including AI/ML-enabled medical devices and novel De Novo submissions. This alignment not only benefits FDA but also helps companies in emerging categories get clearer, faster guidance.
Which Devices Are Eligible?
Here's the catch: Not every device qualifies for third-party review. FDA maintains specific eligibility criteria focused on low-to-moderate risk devices.
General Eligibility Factors:
Device must be Class I or Class II
Device cannot be permanently implantable
Device cannot be life-sustaining or life-supporting
Device type must be specifically eligible per FDA's determination
Ineligible Device Characteristics:
Class III devices (always require PMA, not eligible)
Life-sustaining or life-supporting devices
Permanently implantable devices
Devices with insufficient public health justification for third-party review
Finding Eligible Device Types
FDA maintains a searchable database of eligible device types at their Third-Party Review Program page. You can search by:
Device type or regulation name
Product classification code
Review Organization capabilities
Example Eligible Devices:
Many surgical instruments and tools
Certain diagnostic equipment
Select monitoring devices
Various reusable medical equipment
Example Ineligible Devices:
Cardiac pacemakers (permanently implantable)
Ventilators (life-sustaining)
Implantable cardioverter defibrillators (Class III)
Novel AI-enabled diagnostic devices (typically reserved for FDA review)
How FDA Determines Device Eligibility
FDA updated eligibility criteria in their November 2024 final guidance based on several factors:
Risk Assessment: FDA evaluates the overall risk the device type presents to patients. Higher-risk devices remain under direct FDA review.
Device Complexity: Straightforward devices with well-understood technology and established predicates are better candidates than novel or complex technologies.
Public Health Considerations: FDA considers whether third-party review adequately protects public health for that device type, including consideration of potential failure modes and consequences.
Regulatory History: Device types with consistent, predictable review patterns are more suitable for third-party review than those requiring nuanced scientific judgment.
FDA-Accredited Review Organizations
Not just anyone can review 510(k) submissions. FDA accredits organizations meeting strict criteria under section 523(b) of the FD&C Act.
Current Accredited Organizations
As of October 20, 2025, FDA lists the following 3P510k Review Organizations:
AABB
BeanStock Consulting
Center for Measurement Standards of Industrial (ITRI)
COLA, Inc
Global Quality and Regulatory Services
Regulatory Technology Services, LLC
Third Party Review Group, LLC
Each organization has specific device types they're accredited to review—not all Review Organizations can review all eligible devices. Always confirm the latest roster on FDA’s site.
Organization Capabilities Vary
When searching for a Review Organization, check:
Which device types they're accredited to review
Their experience with devices similar to yours
Their review timelines and fee structures
Their communication practices and responsiveness
Step-by-Step: How to Use Third-Party Review
Step 1: Verify Device Eligibility
Search FDA's eligible device database using your device classification or product code. Confirm your specific device type qualifies for third-party review.
Step 2: Identify Accredited Review Organizations
Find Review Organizations accredited to review your device type. FDA's database shows which organizations can review specific product codes.
Step 3: Contact Multiple Review Organizations
Request proposals from 2-3 accredited organizations. Compare:
Review timelines
Fee structures
Experience with similar devices
Communication processes
Step 4: Select Review Organization and Contract
Choose your Review Organization and execute their contract. Understand their review process, information request procedures, and communication expectations.
Step 5: Prepare Authorization Letter
Draft a letter authorizing the Review Organization to:
Discuss your 510(k) with FDA
Forward the submission to FDA on your behalf
Act as your representative for this submission
Include:
Review Organization name
Assigned reviewer name and contact information
Device trade name
Your authorization signature
Step 6: Submit Complete 510(k) Package
Provide the Review Organization with your complete 510(k) submission in their requested format, including all supporting data, test results, and documentation.
Step 7: Respond to Review Organization Requests
The Review Organization may request additional information or clarification during their review. Respond promptly and completely to avoid timeline delays.
Step 8: Review Organization Forwards to FDA
Once satisfied with their review, the organization forwards to FDA:
Your original 510(k) submission
Their technical review documentation
Their recommendation (Substantially Equivalent or Not Substantially Equivalent)
Step 9: FDA Makes Final Decision
FDA reviews the third-party package and makes final clearance determination within ~30 calendar days of receiving the complete review package.
When Third-Party Review Makes Sense
Ideal Candidates:
Your device clearly fits an eligible device type
You value predictable FDA decision timelines (30-day final review)
Your device is straightforward with strong predicate comparison
You're comfortable working with a Review Organization
When to Stick with Traditional FDA Review:
Your device is borderline eligible or novel
You want direct FDA interaction throughout review
Your device involves cutting-edge technology (AI/ML, novel materials)
You need FDA's specific expertise for your device type
Third-party Review Organizations lack experience with your device type
Common Misconceptions About Third-Party Review
Misconception #1: "Third-party review is always faster"
Reality: Third-party review timeline varies by organization and device complexity. The targeted 30-day FDA decision after third-party review is fast, but total timeline depends on third-party review duration.
Misconception #2: "Third-party clearance is easier to obtain"
Reality: Review Organizations use the same FDA standards and requirements. Third-party review isn't a shortcut around regulatory requirements—it's an alternative review mechanism with identical standards.
Misconception #3: "FDA rubber-stamps third-party recommendations"
Reality: FDA conducts independent review of third-party packages and can disagree with recommendations. FDA makes all final clearance decisions.
Misconception #4: "All low-risk devices qualify"
Reality: Only specifically eligible device types qualify. Many Class I and II devices aren't eligible for third-party review.
Misconception #5: "You can't communicate with FDA during third-party review" Reality: Third-party Review Organizations may engage FDA during their review for clarification on standards or requirements, and sponsors can use pre-submission meetings for early feedback.
The November 2024 Guidance Updates
FDA released final guidance on November 21, 2024, updating the Third-Party Review Program framework.
Key Updates:
Clarified Eligibility Factors: The guidance explicitly describes factors FDA uses to determine device eligibility, including risk assessment, device complexity, and public health considerations.
Enhanced Quality Expectations: FDA articulated specific quality, consistency, and conflict prevention expectations for Review Organizations.
Conflict of Interest Requirements: Detailed requirements for Review Organization personnel to avoid financial conflicts of interest during reviews.
Recognition and Rerecognition Process: Updated procedures for FDA recognizing, rerecognizing, suspending, or withdrawing recognition of Review Organizations.
Emergency Use Authorization Connection: The guidance also addresses third-party review for EUA requests during public health emergencies, though this primarily applies to in vitro diagnostic products.
Making the Strategic Decision
Calculate Total Cost Savings: For most standard companies paying full FDA 510(k) fees, third-party review can provide meaningful savings since FDA does not collect a user fee for 3P510k submissions.
Evaluate Timeline Predictability: The targeted 30-day FDA decision period after third-party review provides timeline certainty for the final review stage, valuable for launch planning and investor communications.
Assess Device Fit: Devices that clearly match eligible categories with straightforward substantial equivalence arguments are ideal third-party candidates. Borderline devices or novel technologies are better suited for direct FDA review.
Consider Strategic Relationships: Some companies prefer building direct FDA relationships through traditional review, especially if planning multiple future submissions or seeking Breakthrough Device designation.
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Frequently Asked Questions
Can I switch from traditional review to third-party review mid-process?
No, you must decide before submission. You cannot transfer an already-submitted traditional 510(k) to third-party review.
What happens if the Review Organization recommends NSE (Not Substantially Equivalent)?
FDA reviews the recommendation and makes the final determination. If FDA agrees with NSE, you'd pursue De Novo or PMA pathways like any NSE decision.
Can I use Pre-Submission meetings for devices going through third-party review?
Yes, you can still use FDA's Pre-Submission program to discuss regulatory strategy before choosing traditional or third-party review pathways.
Do third-party reviewed devices get the same clearance status?
Yes, 510(k) clearance through third-party review is identical to traditional 510(k) clearance in every way.
Can I appeal FDA's final decision after third-party review?
Yes, the same appeal mechanisms available for traditional 510(k) decisions apply to devices reviewed through third-party Review Organizations.
How do I find the best Review Organization for my device?
Contact multiple organizations accredited for your device type, request proposals, check references, and evaluate their experience with similar devices.
