TPRG Frequently Asked Questions
Answers to help navigate third-party FDA review.
Frequently Asked Questions
This FAQ addresses common questions about the FDA Third Party Review Program
and TPRG’s role as an FDA-recognized third party review organization.
What types of devices are eligible for Third Party Review?
More than 1,500 device types are eligible for review under the FDA Third Party Review Program. Eligibility depends on device classification and inclusion in the program. To determine whether a specific device is eligible, please contact TPRG.
Are Special 510(k) submissions eligible?
Yes. TPRG is accredited to review eligible Special 510(k) submissions in accordance with FDA Third Party Review Program requirements.
What types of submissions are not eligible?
Premarket Approval (PMA) submissions and submissions for devices not included in the FDA Third Party Review Program are not eligible.
What happens if a device was previously reviewed by FDA and not cleared?
Initial 510(k) submissions for a device that was previously reviewed by FDA and not cleared are required to be submitted directly to FDA rather than through the Third Party Review Program.
How long does the Third Party Review process typically take?
TPRG's review of an eligible submission is typically completed within approximately 10-15 days, depending on submission completeness and device-specific factors.
What happens after TPRG submits its recommendation to FDА?
After TPRG submits its formal recommendation, FDA reviews the submission and issues the final decision, FDA has up to 30 days to respond, although responses are often issued sooner.
What happens if FDA has questions after TPRG submits its recommendation?
After TPRG submits its formal recommendation, FDA reviews the submission and issues the final decision, FDA has up to 30 days to respond, although responses are often issued sooner.
How do I get started with TPRG?
To learn more about Third Party Review through TPRG or to begin the process, please contact TPRG.
What is the fastest FDA 510(k) pathway?
For eligible Class II medical devices, the FDA Third Party Review Program can provide a faster alternative to the traditional FDA review pathway. Accredited Third Party Review Organizations like TPRG conduct the primary review and submit a recommendation to FDA, helping reduce overall review timelines while maintaining regulatory rigor.
Can a Third Party Review Organization clear my device?
No. Third Party Review Organizations do not have the authority to clear medical devices. TPRG conducts the review and submits its recommendation to FDA, but the FDA retains full authority to make the final clearance decision.
Does FDA still make the final decision?
Yes. FDA maintains oversight of the Third Party Review Program and reviews the recommendation submitted by TPRG. The agency is responsible for issuing the final clearance determination for eligible 510(k) submissions.
What happens after TPRG submits its recommendation?
Once TPRG completes its review, a recommendation package is submitted to FDA for final consideration. FDA reviews the recommendation and supporting documentation before issuing a clearance decision or requesting additional information if needed.
What devices are eligible for FDA Third Party Review?
Many Class II medical devices that meet FDA eligibility requirements may qualify for Third Party Review. Eligibility depends on the device type and applicable FDA regulations. TPRG can help determine whether your submission qualifies for the program.
How long does the FDA Third Party Review process take?
Review timelines vary based on device complexity and submission quality. However, many manufacturers choose the Third Party Review pathway because it can provide a more predictable and efficient review process compared to traditional FDA review routes.