What is FDA Third Party Review?

When Time to Market Matters! Consider the potential revenue that could be generated by obtaining clearance months earlier. TPRG’s experienced review team can get you clearance in as little as 22 days.

How We Can Save You 100 Days

That is over 100 days faster than submitting directly to the FDA. As an example, a cleared medical device sold at a unit cost of $8,500, factoring projected sales of 10 devices per month over a 100 day period, would yield additional company revenue valued at $255,000.

We understand the need for you to obtain FDA clearance as soon as possible. TPRG can get you clearance in approximately 22 to 35 days from submission.


Advantages TPRG Can Provide your Company

Third Party Review is TPRG’s Only Business and Sole Focus that provides you with:

    • Fast Clearance – on average within 22 to 35 days
    • Efficiency and Flexibility
    • Competitive Costs
    • Experienced Reviewers
    • Timeliness
    • Better Quality of Service
    • Workflow Methodology
    • Eliminates your need to pay FDA User Fee

We are dedicated to delivering excellent customer service and enthusiastic about creating honest and responsive relationships with all our clients so we can provide the best Third Party Review in the industry. We will guide you to better results faster!

Our experts will quickly and confidentially determine if your 510(k) is review eligible under Third Party guidelines. Once confirmed, simply submit your 510(k) to TPRG just as you would FDA and we will guide you through our simplified review process.

We promote direct client interaction with your personally assigned reviewer and project manager during the review process. As a result of building this client relationship, TPRG review times average ± 30 days.

Our commitment doesn’t end once our review is complete. We will manage your submission thru FDA’s final review and determination.

Learn how TPRG is formally recognized and accredited by FDA to perform premarket notification third-party reviews.