FAQ

Frequently Asked Questions

 

510K

There is a fast way to get a 510K cleared. Did you know you can get your 510K clearance in as little as 45 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. Contact The Third Party Review Group, we are the experts in 510K review and can help you today. Call us at 973-232-0811 or email us at info@fdathirdpartyreview.com.

 

FDA 510K or 510K FDA

There are two lanes to get FDA 510K clearance. The regular FDA 510K clearance process or the TPR FDA 510K clearance process. With the regular FDA 510K clearance process it may take 100 days or longer to receive clearance but if you use the TPR FDA 510K process you can receive clearance in as little as 45 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. Call us today at 973-232-0811 to receive your FDA 510K clearance today.

 

510K Means

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. Contact us today to find out if your device is eligible at 973-232-0811 or email us at info@fdathirdpartyreview.com.

 

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 the expert in 510K TPR clearances. Contact us today to find out if your device is eligible at 973-232-0811 or or email us at info@fdathirdpartyreview.com.

 

TPRG is the leader in third party reviews!

Expedite your FDA Clearance. Take advantage of the FDA TPR program. The TPR program, launched and managed by the FDA can get your 510K clearance within 40 to 60 days.

Contact us today to find out if your device submission qualifies at info@fdathirdpartyreview.com

 

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 40 to 60 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 40 to 60 days if your device qualifies for this very special program.

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

 

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.

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 40 to 60 days. Contact us now for more information.

 

What are the differences between Third Party Review and Traditional FDA Clearance?

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 40 to 60 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.

 

Why should I go with the Third Party Review Group?

Great question. The Third Party Review Group is a boutique agency accredited by the FDA to review some 510K’s on their behalf. 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.

 

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 40 to 60 days. Contact TPRG now.

 

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 40 to 60 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.

 

NEW! 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.

 

NEW! 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 45 to 60 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.