FAQ

Frequently Asked Questions

 

How Fast Can I Get My 510K Cleared?

There is a fast way to get a 510K cleared. Did you know you can get your 510K clearance in as little as 22 days? The Third Party Review Group is an FDA accredited 510K review agency. The FDA TPR program is designed to provide clearance for your 510K fast and puts your 510K at the front of the line. For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

What Is The Difference Between Going Direct To The FDA Or Using The TPR FDA 510k Program?

If you are eligible you can save significant time in the FDA clearance process. Over 100 days and in some instances over 200 days or longer. With the regular FDA 510K clearance process it is very likely your clearance will take much longer than 100 days. TPRG is an accredited FDA review agency. We can get you through the FDA 510K process in as little as 22 days. The Third Party Review Group is the industry expert in FDA 510K’s and is approved by the FDA to fast track your device. For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

What Does A 510K Mean?

What does a 510k mean? A 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is safe and effective. What a 510K means is that your device is one that is safe, effective and substantially equivalent to one that is currently marketed in the US. When a person asks what a 510K means typically they have a device that they need clearance from the FDA to sell in the US. The Third Party Review Group is the expert in 510K TPR clearances. For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

What Is A 510K Certificate?

When a person asks about a 510K certificate often they are asking about the 510K clearance program or how to receive approval to sell their device in the US. To do this they must create a 510K. A 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is safe and effective. What a 510K Certificate or Clearance means is that your device is one that is safe, effective and substantially equivalent to one that is currently marketed in the US. The Third Party Review Group is approved to provide a much faster clearance than submitting direct to the FDA through the TPR program. This program, designed by the FDA, will get you cleared much faster. Our program can get you cleared in as little as 22 days. For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

Will The Covid-19 Pandemic Impact The Clearance Of FDA Review Products?

As Corovanirus changes everything in our lives, we are happy to let you know that the FDA 510K clearance timeline for devices eligible for the TPR program remains at 22 to 35 Days and is not impacted by COVID 19.

Furthermore, the Third Party Review Group’s expedited process protects clients from a delay in clearance as well. This policy applies to both Domestic and International clientele. That means that you can still receive clearance within 22 to 35 days if your device qualifies for this very special program.

TPRG saves you time and money during the FDA Clearance Review.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

Am I Required To Pay The FDA MDUFA Fee When Participating In The FDA TPR Program?

The MDUFA fee is the fee for the traditional FDA program. Because you are taking advantage of the FDA TPR (third party review) program you are not required to pay the MDUFA Fee.

Often times the fee for TPR is less than the fee for the traditional FDA program. The Third Party Review Group’s specially designed process creates a faster, leaner more interactive process that save you time and money. Clearance can be achieved in 22 to 35 days.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

What Are The Differences Between Third Party Review And Direct Submission To The FDA?

Third Party Review and Traditional FDA Clearances are both FDA programs. The Third Party Review program was created by the FDA to off a faster clearance timeline for some medical devices. The benefits of this program are money, time and ease of interaction. The potential revenue that you could receive by getting your device to market faster is substantial.

The time to clearance is typically 22 to 35 days and the interaction with a highly qualified reviewer is invaluable. The Third Party Review Group has over 100 years combined experience and can help demystify the clearance process so that you get to market fast. Contact TPRG now to discuss your situation.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

Why Should I Go With The Third Party Review Group?

Third Party Review Group has been accredited by the FDA for 13 years. The Third Party Review Group has over 100 years combined experience and brings a highly interactive, nimble process to our clients.

The Third Party Review Group has the experience to understand the requirements and guidelines and has created a very simple and efficient process. We get you cleared fast allowing you to move forward with your business. Contact Third Party Review Group today.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

What Is EUA Or Emergency Use Authorization?

The EUA or Emergency Use Authorization is authorization to use a device in an emergency that does not have FDA clearance when there is no adequate, approved and available alternatives. This is a short term authorization and if you would like to continue marketing your device in the US you will need to receive 510K clearance from the FDA. The Third Party Review Group can help you receive expedited clearance so that you will not need to take your device off the market while waiting for clearance through traditional routes. As an FDA accredited reviewer we review 510K’s on their behalf. Your device can be cleared in 22 to 35 days. Contact TPRG now.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

Can I Receive EUA Registration And Also Apply For FDA clearance?

Yes. You can receive EUA registration to get your device to the people who need it most during this COVID emergency. If you would like to continue to market your device in the US you will need 510k clearance. TPRG can get your device cleared in as little as 22 to 35 days. With over 100 years combined experience coupled with our proprietary process we deliver an efficient and fast experience for our clients. Contact us today to learn more.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

Did You Know The FDA MDUFA Fee Is Waived When Choosing The FDA Expedited Or TPR Program?

The advantage is a special 510K timeline that expedites your clearance while waiving the FDA MDUFA fee. Third Party Review Group is one of the only FDA accredited agencies that reviews 510K submissions under this program. Please contact us today to verify your product code qualifies for this special 510K timeline and waives your MDUFA.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.

 

What Is The Difference Between Expedited And Traditional FDA 510k Processes?

Once your 510K is ready to submit, there are two FDA 510K processes. The first is the traditional program and the second is the expedited or TPR program. The TPR program offers a special 510K timeline that speeds the FDA 510K process. The timeline to FDA clearance is approximately 22 to 35 days. Third Party Review Group is one of the only FDA accredited agencies that reviews 510K submissions under this program. Please contact us today to verify your product code qualifies for this special 510K timeline and waives your MDUFA.

For immediate assistance, contact Catherine Read, VP Global Sales at 408-838-5325 or email at cread@fdathirdpartyreview.com. You can also call our offices direct at 973-232-0811.