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...Read More
TPRG is the missing piece of the puzzle that can help you take your medical device to market. We understand...Read More
THE LEADING FDA ACCREDITED REVIEW BODY
Third Party Review Group is accredited to review Medical Device Submissions on behalf of the FDA as part of the Third Party Review Program. The program allows clients to fast track their 510k submissions reducing time to market by 100 days on average.
TPRG’s OUTSTANDING SERVICES
- TPRG has been in business 14 years and has been continuously recognized and accredited by FDA to perform Premarket Notification [“510(k)”] third-party reviews for all eligible devices identified in the program.
- Our accredited review capabilities encompass 7 FDA Office of Health Technology Divisions that reach across 14 Device Branches.
- Applicants submit their 510(k) directly to TPRG in lieu of FDA saving them precious review time and expediting their device clearance into US commerce.
- We manage the entire review process for each applicant from the time of formal submission through the final substantial equivalence determination rendered by FDA.
- Performing third party reviews is our sole business focus as we accurately and rapidly serve the needs of our customers.
GET TO MARKET FAST
22 to 35 Days Average Time To Clearance!
Save An Average Of 100 Days With This Expedited Process.
FDA COST WAIVED
Average Price Is Less Than The FDA Traditional Program!
Speak with Our Sales Team Today.
Our Reviewers Have Over 30 Years Reviewing Experience!
Learn About All Our Latest Tips.
FDA SUBMISSION 101
Still Confused About The Process?
Watch A Movie That Explains It All!
NEW! RAPID 510(k)
EVEN FASTER SUBMISSIONS
Enhanced ‘Speed To Market’ Option.
Greater, Faster Feedback And Results!
ASK US HOW
- Our customers include some of the top 10 Global Device Manufacturers along with medium size companies thru small start-ups.
- TPRG’s current customer portfolio includes new and repeat clients located throughout the US, Canada and over 10 additional international locations.