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• TPRG is formally 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 Device Evaluation Divisions that reach across 13 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.
• 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.
FDA Accredited 510(k) Third Party Reviewer
Service Focus
Customer Base
TPRG is headquartered in Manhattan, NY. Our office located in Belfast, Northern Ireland extends coverage to Europe and Asia.
A satellite office located in San Diego, CA enhances US coast-to-coast operations.
On-call 24 hour service is available and focused on enhancing support to our international customers.
510(k) reviews are supported through open dialogue by a pool of 20 TPRG FDA accredited reviewers averaging over 25 years of medical device industry experience.
Includes prior FDA staff members.
FDA Accredited 510(k) Third Party Reviewer
TPRG US Headquarters Customer Base
Europe and Asia Regional Office
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FDA Accredited 510(k) Third Party Reviewer
• The Third Party Review program was introduced by the FDA as an option forINDUSTRY to fast track the 510(k) review process and facilitate marketing low-to-moderate risk Class I and Class II devices into US commerce. To support the program, private companies began offering a solution by forming accredited Third Party Review services focused on lessening the workload of FDA, enabling them to use its scientific review resources for higher-risk devices.
• In order to better serve industry, TPRG was formed, FDA accredited and has been successfully performing reviews since 2011. Our team is comprised of a seasoned consortium of scientific accredited reviewers and administrative support staff chartered to meet the intent of the Third Party Review program coupled with our customer needs.
• During the past three years, we have developed a special working relationship with the FDA that has served our customers well. We possess a clear understanding of the detailed 510(k) internal review process and possess the scientific review skills required to perform this important service to industry.
Industry
TPRG
FDA
FDA Accredited 510(k) Third Party Reviewer
Upon formal receipt of each submission, TPRG assigns a Primary and Senior reviewer
[at minimum] and completes the standard FDA acceptance checklist. This phase of the
review ensures the major 510(k) components are present and comply with current FDA
standards. In addition, we verify eCopy compliance.
Applicants are notified of any identified checklist deficiencies. TPRG will then begin the
substantive portion of the review.
The substantive portion of the review begins with our focus pointed toward determining
device substantial equivalence. This is a very interactive phase of the review allowing the
applicant and their assigned reviewers an open line of communication.
TPRG performs a scientific assessment, formally documents the review and finalizes its
recommendation to the FDA -- completing this phase of the review.
TPRG will finalize the review and forward all required documentation to the FDA on behalf
of the applicant and obtain the uniquely assigned 510(k) number. TPRG will manage all
FDA communication for the applicant during this final review phase.
By law, FDA has 30 calendar days to complete their determination of substantial
equivalence based on our recommendation thus completing the review cycle.
10 days
20 days
30 days
±
±
≤
60 days±
Administrative Review Phase
Substantive Review Phase
FDA Review Phase
FDA Accredited 510(k) Third Party Reviewer
• We understand the need for industry to obtain FDA clearance as soon as possible. Since the inception of TPRG, submissions reviewed by FDA averaged approximately 165 days. During this same time, submissions reviewed by TPRG averaged 65 days.
60
55
55
175
160
160
0 50 100 150 200
CY 2011
CY 2012
CY 2013
FDA TPRG
510(k) Clearance Average in Calendar Days
Time to market matters! Consider the potential revenue that could be generated by obtaining clearance 3-4 months earlier by using TPRG. As an example, a cleared medical device sold at a unit cost of $8,500, factoring a projected sales of 10 devices per month over a 100 day period, would yield additional company revenue valued at $255,000.
Total Quantity 30
Un
it P
rice
$8
.5K
Revenue $255K
Revenue Potential Over 100 Day Period
FDA Accredited 510(k) Third Party Reviewer
FDA MDUFA Fee Exempt
Expedited Review Cycle
Open Communication Channels
Insight Into Current FDA Compliance Concerns
Optimizes Staff Availability for Other Projects
Enhanced Revenue Opportunity
Administrative Workload Lifted
We value our customers and the service we provide!
FDA Accredited 510(k) Third Party Reviewer
“My experience with TPRG has exceeded both my expectations and previous experiences with third party reviewers. TPRG
commits to review timelines, and they meet them. This helps reduce submission review time variability, which in turn helps
me meet my commitments to my business. TPRG’s staff is very professional, and the communication channels are always open. I appreciate their commitment to continuous improvement and
the solicitation of feedback after the review process is complete. I will continue to use TPRG for my 510(k) reviews.”
“I am thoroughly impressed by the excellent service that Third Party Review Group, LLC provides. Arteriocyte Medical
Systems, Inc. utilized Third Party Review Group for a 510k submission to the Center for Devices and Radiological Health,
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices. Third Party Group, LLC
was able to facilitate a review and approval during a government shutdown clearly demonstrating their expertise, project management, and adherence to timelines. As a result
of our partnership with Third Party Review Group, LLC, we were able to meet our goal of bringing our product to the
marketplace in a timely fashion.”
“ It was a pleasure working with TPRG! After using other Third Party Reviewers in the past we were skeptical of using
the service again but were extremely pleased with the process and quick review time. We plan to use their service
for future eligible submissions.”
“We were very satisfied with the review process. The review was conducted efficiently and TPRG was able to conduct a very
comprehensive and thorough review within a very short turn time. We were also very impressed with the attention to details of the reviewers.
Our assigned reviewers were very knowledgeable. During the initial review process, we were impressed by the level of detail of the initial
response from TPRG. The level of detail on the questions asked especially on the Software section shows that all the reviewers are very
knowledgeable on their respective areas. We were also impressed on the knowledge demonstrated by the lead reviewer on the overall review process, the sterilization section and that lead us to FDA clearance.”
“Top 10 Global Medical Device Company”“Arteriocyte Medical Systems, Inc.”
“Top 15 Global Medical Device Company”
“International Device Company”
