The Accredited Persons Program was implemented by the FDA themselves to assist with handling 510(k) submissions. The reason why the FDA thought it necessary to have this program in place was due to the large amount of submissions forwarded to them each year. It was discovered that people who had submitted 510(k) applications were having to wait an extensive length of time for their submission’s to complete the entire process. The solution to the problem was achieved thanks to the Accredited Persons Program. Those in the program are able to carry out the 510(k) submissions in a reduced time period, therefore providing a better service with faster results.
This program was created by the FDA Modernisation Act of 1997 and has since become the fastest route towards having your medical device cleared with flying colours in a short space of time. However, some people still prefer to submit directly to the FDA, without being aware of the time differences between the two different routes of completing a successful 510(k).
What is the 510(k) Process?
The 510(k) process, according to the FDA, involves clearing eligible medical devices. It acts as a premarket submission to the FDA with the intention to prove that the intended device is both safe and effective, thus enabling it to be marketed as appropriate. The device itself bust be substantially equivalent to an existing marketed device as deemed relevant by the FDA. The 510(k) process itself is quite time consuming, especially if you are in a hurry to clear your medical device.
Advantages of Accredited Persons
As mentioned above, an accredited person, otherwise known as a third party review program, are authorised to partake in the FDA 510k clearance process. Companies such as http://www.fdathirdpartyreview.com are not only able to carry out this review, but they can do so in a shorter time period, providing results faster than if you were to submit directly to the FDA.
The process involves analysing the device to ensure that it meets FDA standards. The third party review program will also decide if your device is eligible or not. The same program, once each stage is completed, will then forward your application and their findings to the FDA. The best part about this is the fact that because your review has been submitted by an Accredited person, the FDA is, by law, required to complete your review and exhibit the final decision within a time frame of 30 days.
About2ZF77
