Third Party Review Group

What Third Party Review Group does

Third Party Review Group, LLC (TPRG) is a Henderson, Nevada-based, FDA-accredited Third Party Review Organization founded in 2012. The firm provides independent 510(k) reviews for eligible Class II medical devices, conducting substantive review and submitting recommendations to the FDA for final clearance decision under the FDA's Third Party Review Program (accreditation party_key=7). TPRG's reviewers each bring an average of 30+ years of FDA and medical device industry experience, and the firm applies a disciplined, multi-phase review process — including submission readiness assessment, acceptance review, and substantive review — aligned with FDA expectations. TPRG accepts submissions in the FDA eSTAR electronic format and reports typical review timelines of 10-15 days for the TPRG phase and 30-45 days to final FDA decision, materially faster than traditional FDA review pathways.

The company's product surface centers on its core FDA Third Party Review Services for 510(k) submissions, supplemented by a pre-submission Eligibility Review Service that helps manufacturers assess device classification, product code, and predicate strategy before committing to a full submission. Eligible device categories include Class II devices and incremental design-change devices with clear predicate devices, as well as eligible Special 510(k) submissions; more than 1,500 device types are eligible under the program. Services are delivered directly to manufacturers — no resellers or channel partners are used — through a consultative sales motion via phone, email, and an online eligibility review request form.

TPRG operates on a quote-based, project-by-project professional services fee model with multi-year contract billing cadence; pricing is not publicly disclosed. The firm is privately held, founder-owned, and independently operated with no parent company, institutional investors, or venture capital backing documented. It serves Class II medical device manufacturers across the United States from a single Henderson, Nevada headquarters, with no international footprint and no disclosed M&A, partnership, or funding activity in the available data.

Name

Third Party Review Group

Legal name

Third Party Review Group, LLC

Website

https://fdathirdpartyreview.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Third Party Review Group (TPRG) is an FDA-accredited Third Party Review Organization that conducts primary 510(k) reviews for eligible Class II medical devices, serving US-based manufacturers with accelerated clearance timelines of 30-45 days.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Review Services

akta.pro primary industry

Compliance, Reporting & Regulatory Administration (ERISA/ACA/No Surprises) (HLAEALAJ)

Keywords

• FDA 510(k) review
• Medical device regulatory
• Third party review
• Class II device review
• Regulatory clearance services

Headquarters

HQ city

Warren

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. 510(k) Third Party Review Services: TPRG charges medical device manufacturers for conducting primary 510(k) reviews as an FDA-accredited Third Party Review Organization. Revenue is generated through professional services fees for regulatory review of eligible Class II device submissions, with pricing based on project scope and submission complexity.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Third Party Review Group (TPRG) is an FDA-recognized Third Party Review Organization that conducts independent 510(k) reviews of eligible Class II medical devices and submits recommendations to the FDA for final clearance. The company also provides a pre-submission Eligibility Review Service that assesses device classification, product code, and predicate device strategy to determine if a manufacturer's submission qualifies for the Third Party Review Program.

Product overview

Third Party Review Group offers a single unified service offering centered on FDA Third Party Review Program services for 510(k) submissions. The core product is FDA Third Party Review Services, where TPRG conducts primary reviews of eligible Class II medical device submissions and submits recommendations to FDA for final clearance. An ancillary Eligibility Review Service supports manufacturers in assessing device qualification before committing to the full submission process. TPRG's reviewers bring 30+ years of FDA and industry experience and operate under FDA oversight throughout the review.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA Third Party Review Services Independent 510(k) reviews for eligible Class II medical devices, in which TPRG conducts substantive review of the submission and submits its recommendation to FDA for final clearance decision. Targeted at U.S. Class II medical device manufacturers seeking accelerated regulatory clearance.
• Eligibility Review Service Pre-submission assessment that evaluates device classification, product code, predicate device strategy, and Third Party Review Program eligibility before manufacturers invest time and resources in a full 510(k) submission. Targeted at Class II medical device manufacturers considering the third-party review pathway.

Quantifiable outcome

• 30-45 days typical time to FDA decision vs potentially longer traditional review timelines
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators4 records

Recent moves4 records

Expansion highlights1 record

Broad incumbents

• Intertek: Intertek is a global quality assurance and testing company providing medical device regulatory and 510(k) support services, overlapping with TPRG's regulatory review focus within a much broader testing and certification portfolio.
• TÜV SÜD: TÜV SÜD is a global testing, inspection, and certification company that is also FDA-accredited as a Third Party Review Organization for 510(k) submissions, offering overlapping 510(k) review services alongside a much broader medical device testing and certification portfolio.
• BSI Group: BSI is an international standards, testing, and certification body that also acts as an FDA-accredited Third Party Review Organization, offering 510(k) review services as part of a wider medical device regulatory and quality systems portfolio.
• UL (Underwriters Laboratories): UL is a global safety science and certification organization with FDA Third Party Review accreditation, providing 510(k) review and broader medical device testing and certification services to a similar Class II manufacturer base.
• NSF International: NSF is a global public health and safety organization with medical device testing, certification, and regulatory services that overlap with TPRG's 510(k) review work for the same Class II device manufacturer base.
• DEKRA: DEKRA is a global testing, inspection, and certification organization with medical device regulatory services including FDA 510(k) pathways, serving similar Class II device manufacturers through a broader portfolio than TPRG.

Direct peers

• The FDA Group: The FDA Group is a regulatory consulting firm specializing in FDA submission strategy, 510(k) preparation, and quality systems for medical device manufacturers, serving a similar Class II customer base to TPRG with adjacent but partially overlapping services.
• NAMSA: NAMSA is a medical device contract research organization and regulatory consulting firm that supports Class II device manufacturers through regulatory strategy, testing, and submission services closely aligned with TPRG's pre-submission and 510(k) review offerings.
• RQM+: RQM+ is a medical device regulatory consulting and 510(k) review firm serving Class II device manufacturers, with overlapping services in FDA submission strategy, third-party review, and pre-submission gap analysis comparable to TPRG.
• Regulatory Technology Services (RTS): RTS is one of the largest FDA-accredited Third Party Review Organizations providing 510(k) review services for Class II medical devices, directly competing with TPRG in the same regulatory pathway for the same manufacturer customer base.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Third Party Review Group