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 [email protected]. You can also call our offices direct at 973-232-0811.
Direct FDA or TPR FDA 510(k): What’s the Difference?
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 [email protected]. 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 [email protected]. You can also call our offices direct at 973-232-0811.
WHAT ARE THE REQUIREMENTS FOR FDA 510K CLEARANCE?
Simply put to obtain an FDA 510(k) clearance, a medical device must demonstrate that it is substantially equivalent to a legally marketed device. That device is called a predicate device. The electronic Submission Template And Resource (eSTAR) is an interactive PDF form that guides applicants through the process of preparing a medical device submission. All 510K submissions must use this format.
HOW LONG DOES IT TAKE TO OBTAIN FDA 510K CLEARANCE?
The time it takes to obtain FDA 510(k) clearance can vary. The FDA’s goal is to complete the process in 90 to 120 days from the time the FDA receives a properly documented submission. However, often there are delays and the timing is dependent on many factors. To offer an expedited path the FDA created the TPR program.
WHAT CAN I DO TO SPEED UP MY FDA 510K CLEARANCE?
Contact TPRG to find out if you are eligible for the TPR program which will significantly expedite your 510K. Focus on the quality of your submission. A well-prepared and thorough submission can help avoid delays. Planning and preparation, including potentially engaging with the FDA during the pre-submission phase, can help streamline the review process and minimize delays.
CAN FDA 510K CLEARANCE BE EXPEDITED?
Yes. TPRG is honored to be accredited by the FDA to provide expedited reviews under the TPR program. Your 510K clearance can be obtained in as little as 30 days.
HOW DO I SUBMIT A 510K THROUGH THE TPR PROGRAM?
There are three basic steps to submit a 510(k) through the program.
- Determine if your device is eligible. To determine if a 510(k) submission is eligible to be reviewed under this program, please contact TPRG directly at [email protected].
- Schedule your submission with TPRG.
- Submit your 510K in eSTAR format through our encrypted database
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 [email protected]. 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 [email protected]. You can also call our offices direct at 973-232-0811.