The Standard in FDA Third-Party Review
Faster Decisions. Fewer Delays. Built for Clearance.
TPRG Accelerates 510(k) Clearance Through FDA-Accredited Review
TPRG is an FDA-recognized Third Party Review Organization focused exclusively on delivering faster, more predictable 510(k) outcomes.
Our reviewers bring an average of 25+ years of FDA and industry experience, allowing us to identify issues early, minimize review cycles, and reduce the risk of delays. We apply a disciplined, transparent process aligned with FDA expectations – so your submission moves efficiently from review to clearance.
- FDA Third Party Review Program
- Experienced FDA Reviewers
- Clear, Actionable Feedback
Is Third Party Review Right for Your Device?
For eligible 510(k) submissions, TPRG’s process reduces time to clearance and accelerates your path to market.
Well-Suited for Third Party Review
- Eligible Class II devices
- Incremental design changes
- Clear predicate devices
Common Eligiblity Questions
- Is my device eligible?
- Does my submission qualify?
- What is the TPRG process?
Understanding the Third Party Review Process
TPRG offers an alternative to the traditional FDA review pathway through the Third Party Review (TPR) Program – designed to accelerate eligible 510(k) submissions while maintaining full FDA oversight.
TPRG delivers faster review timelines, reduced hold risk, and a disciplined path to 510(k) clearance.