4 Steps of Using a FDA Third Party Review Organisation
You may prefer to submit your 510(k) to a third party review organization rather than submitting directly to the FDA. The purpose of the Accredited Persons Program is to assist the FDA with completing medical device approvals via the 510(k) process. If you choose to take the third party route, you are guaranteed to receive your final results much faster than taking the traditional FDA approach.
This is due to the fact that any applications forwarded to the FDA by one of their accredited persons, such as http://www.fdathirdpartyreview.com, results in a much faster turnaround period of no more than 30 days. Third party review companies such as this simplifies and exhilarates the FDA 510k clearance process, providing people with a faster and more efficient reviewing process.
The Accredited Persons program comes with four simple steps:
Before submitting your device, you must first determine whether or not it is even eligible. To do this, it is worth taking the time to check the long list of eligible devices provided by the FDA. On the list, you will see product codes and classification regulations. If you find yours amongst the batch, then your device will be eligible for 510(k) review.
You must decide which Accredited person will be able to accurately review your 510(k). You can simply do this with a bit of careful research online, or you can go back to the list of eligible devices and click on the product code. This brings up a list of possible third party reviewers that will be able to review your specific product. This information will also include relevant contact details to get in touch with your most suitable company.
The third stage of this process is to obtain various price quotes from different accredited persons. You may find a cheaper offer with some simple research into the field. Different factors will be taken into consideration before you are given a quote such as the estimated time frame of completion.
The final stage is to submit your 510(k) to your chosen accredited person. Your submission should also include your worded consent (in the form of a letter) to say that you have authorized the accredited person to discuss your 510(k) with the FDA.