FDA Third Party Review Specialists It takes one-third of the time to reach a 510K approval with TPRG - 55 days via 160 days. 510(k) in Calendar Days You are welcome to call their epesenttive to the region

2. • 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

3.  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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4. FDA Accredited 510(k) Third Party Reviewer
• The Third Party Review program was introduced by the FDA as an option for
INDUSTRY 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

5. 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

6. 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.
TotalQuantity 30
UnitPrice$8.5K
Revenue $255K
Revenue PotentialOver 100 Day Period

7. 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 RevenueOpportunity
AdministrativeWorkload Lifted
We value our customers and the service we provide!

8. 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”

9. Your Representative Contact
Mary P Ryan
Email: marypryan1@gmail.com
Skype: marypryan1
Tel: +44‐7761069036