What is Third Party Review?
The FDA created the Accredited Persons Program to hasten the 510(k) process for eligible devices. When you choose to submit a 510(k) application directly to the FDA, chances are, you will be waiting a long period of time before you receive any word back. The 510(k) process involves clearing medical devices within the United States and further abroad such as Europe and Asia etc.
Who are the “Accredited Persons”?
Accredited Persons are those who have been given authorisation by the FDA to carry out the initial review of 510(k)’s for certain eligible devices. But that’s not all they do. They also forward the primary review to the FDA and because this application has been submitted by an Accredited Person, the FDA has no choice but to issue the final determination within a period of 30 days. This results in a faster turnaround time and overall quicker results.
What is an Eligible Device?
The term “eligible device” is thrown around like a Frisbee in this busy marketplace. An eligible device simply refers to a device that is deemed “substantially equivalent” in terms of both effectiveness and safety to an existing lawfully marketed device. For a device to be “eligible”, it must showcase similar characteristics as a “predicate” device. This means that it must exhibit the same levels of safety, effectiveness and other important qualities deemed as essential factors by the FDA. If your said device does not meet these standards, it will not be seen as eligible for 510(k) clearance.
510(k) Review Process
When choosing to clear your device via an Accredited Person such as http://www.fdathirdpartyreview.com, there are certain stages of the FDA 510k Clearance Process that will take place. The first stage is referred to as the Administrative Review Phase. This involves the Accredited person receiving receipt of your formal submission. The standard FDA acceptance checklist is then carried out to ensure that your said device is deemed eligible for the 510(K) process or not. Following this, your submission will move onto the substantive review phase. A line of communication is opened between two parties where you can ask any questions you like regarding your submission. A scientific assessment is also carried out, following strict guidelines and recommendations from the FDA. The final stage is the review phase. This is when your review is submitted to the official FDA and as mentioned above, the FDA will have a final response within just 30 days.