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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.
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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?
Request an Eligibility Review

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.

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?
Start Your Path To 510(k) Clearance!

Why TPRG Korea?

Expertise built on experience gives you an efficient, high-quality review process

FDA-recognized and accredited review organization​

Each reviewer brings over 25 years of medical device experience

Led and managed by medical device professionals

Ongoing training and interaction with FDA

REDUCED REVIEW TIMELINES

Typical time frame to FDA decision:

30-45 days

EXPERIENCED TPRG REVIEWERS

  • Multi-device & FDA expertise
  • Documentation standards
  • Structured, consistent reviews

PREDICTABLE PROCESS

  • Defined review phases
  • Clear communication
  • Formal FDA recommendation

Contact TPRG Korea

Taeri Im
Executive Representative

Phone +82 70 8080 5815
Email taeri.im@fdathirdpartyreview.com
LinkedIn  http://linkedin.com/in/taeriim-tprg-korea

     

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