A Faster, Structured Path to FDA Clearance
Clear steps from submission readiness to FDA clearance.
Third Party Review Process
Submission Readiness
Acceptance Review
Substantive Review
FDA Clearance
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?
Is the product code eligible?
Are you looking for a faster path to clearance?
Understanding the Third Party Review Process
The FDA 510(k) Third Party Review Program provides an alternative review pathway for eligible medical devices. Under this program, FDA-recognized Third Party Review Organizations conduct primary reviews of 510(k) submissions using FDA-equivalent criteria and submit a formal recommendation to the Agency for final determination.
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.