Third Party Review Group

Third Party Review Group (TPRG) is an FDA-accredited review organization specializing exclusively in third-party 510(k) medical device submissions. Established in 2010 and headquartered in Madison, New Jersey, TPRG serves medical device manufacturers globally with satellite offices in San Diego, the San Francisco Bay Area, and South Korea. The company has maintained continuous FDA accreditation for 14 years across 7 FDA Office of Health Technology Divisions covering 14 Device Branches.

TPRG's review capabilities span over 1,200 product codes across medical device categories including anesthesiology, cardiovascular, dental, orthopedic, radiology, and ophthalmic devices. The organization manages the entire review process from submission through final substantial equivalence determination, with reviewers averaging 30 years of FDA submission experience. Their client portfolio includes top 10 global device manufacturers as well as medium-sized companies and startups across the US, Canada, and international markets.

The company reports average clearance times of 22-35 days, potentially saving clients approximately 100 days compared to direct FDA submission. TPRG offers a 'Rapid 510(k)' option for manufacturers seeking even faster market entry.

Choose TPRG when time to market is critical for your 510(k)-eligible medical device and you need experienced regulatory guidance. Their exclusive focus on third-party reviews and deep FDA accreditation makes them particularly valuable for manufacturers launching devices in competitive categories where 100-day time savings can translate to significant revenue advantages.

Expect a managed end-to-end process with detailed reviewer feedback, commitment to established timelines, and expertise spanning hardware, software, and combination devices. The firm's global office network supports international manufacturers entering the US market.

TPRG operates exclusively within the medical device regulatory sector as an FDA-accredited third-party review organization. Their healthcare specialization encompasses 14 medical device branches including anesthesiology, cardiovascular, dental, gastroenterology, neurology, obstetrics/gynecology, ophthalmic, orthopedic, physical medicine, radiology, and infection control devices. The company maintains formal FDA recognition to review Premarket Notifications on behalf of the agency, serving as a direct alternative to traditional FDA submission channels for eligible medical devices.

Medical device manufacturers with 510(k)-eligible products seeking expedited FDA clearance, particularly those in competitive markets where 3-4 month time savings justifies premium review services. Companies range from global top-10 manufacturers to startups, including international firms requiring US market entry guidance. First-time 510(k) applicants benefit from their structured guidance and experienced reviewer feedback.