A Faster, Structured Path to FDA Clearance
Clear steps from submission readiness to FDA clearance.
Third Party Review Process
Submission Readiness
Before review begins, TPRG evaluates submission completeness, device eligibility, and required documentation. Early identification of gaps helps reduce review delays and supports a more efficient path to FDA clearance.
Acceptance Review
TPRG conducts an administrative and regulatory assessment to confirm the submission meets FDA acceptance criteria. Any missing information is identified early so issues can be resolved before substantive review begins.
Substantive Review
Experienced reviewers evaluate the device against applicable FDA requirements, predicate comparisons, and supporting performance data. Clear feedback helps address questions efficiently and minimize additional review cycles.
FDA Clearance
Upon completion of the review, TPRG submits its recommendation package to FDA for final consideration. FDA retains full regulatory authority and issues the final clearance decision.
Typical Review Timelines
Traditional FDA Review
Third Party Review
Timelines vary by submission.
TPRG vs. FDA Responsibilities
TPRG
Acceptance Review
Substantive Review
Recommendation
FDA
Final Clearance
Regulatory Authority
Post-Clearance Actions
Is Your Device Eligible?
Is the device Class II?
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Are you looking for a faster path to clearance?
Understanding the Third Party Review Process
TPRG offers an alternative to the traditional FDA review pathway through the Third Party Review (TPR) Program.
The FDA Third Party Review Program permits accredited review organizations to perform the primary review of eligible Class II 510(k) submissions. Throughout the process, TPRG works closely with manufacturers to identify potential deficiencies early, promote predictable review timelines, and facilitate efficient communication while operating under FDA oversight and final authority.
Step 1 - Submission and Acceptance to TPRG
● The submitter provides a complete 510(k) submission using the required eSTAR format.
● TPRG performs an acceptance assessment to confirm administrative completeness.
● If required elements are missing, the submitter will be immediately notified.
Step 2 - TPRG Begins the Second Phase of Review
● TPRG conducts a substantive review using the same criteria applied by FDA.
● Any deficiencies identified during review are communicated to the submitter, with an opportunity to respond.
● TPRG documents its review findings in accordance with FDA Third Party Review Program requirements.
Step 3 - TPRG Submits Formal Recommendation to the FDA
● Upon completion of the review, TPRG submits the full review package and its formal recommendation to FDA.
● FDA conducts its review of the submission and issues the final determination regarding clearance.