The FDA designed and created the Accredited Persons Program to assist with the initial review process of 510(k) for certain devices deemed as being low to moderate on the “risk scale”. This allows the FDA to concentrate on devices reviews to be at a much higher risk whilst the Accredited Persons conduct initial reviews of other devices that require FDA approval.
510(K) Completion Time Period
Usually, the FDA would take quite some time to review and complete a 510(k) submission. This is because, as mentioned above, they have a huge line up of submissions to get through with some devices deemed as higher risk devices than others. Choosing an accredited person to assist with your 510(k) is a wise choice because it takes far less time to obtain a finalised decision. For example, if you were to submit your 510(k) directly to the FDA, you could be waiting for months on end for any kind of response.
However, allowing an accredited person such as http://www.fdathirdpartyreview.com to complete your FDA 510k clearance submission, means that your submission receives the same reviewing standards by that of the FDA and once the Accredited Person forwards the submission to the FDA, you will receive your results in less than 30 days.
Accredited Person Requirements
Before being assigned as an accredited person, proper FDA assessment, accreditation and training is required. According to the FDA, the accredited person is required to assist with the 510(k) submissions of all class III devices and any class II devices that are seen as permanent implants or are life-supporting/life-sustaining devices. The main purpose of an accredited person is to improve the timeliness and overall professional efficiency of FDA’s 510(k) process. In order for a medical device to receive marketing clearance in the US, it must be FDA approved. A primary review is carried out by the accredited person and is then forwarded to the FDA.
What is the Expansion Pilot?
The FDA decided to expand the Accredited Persons Program by introducing the expansion pilot. This means that certain Class II devices are now able to be reviews by an Accredited person, which was previously not available to the public. This was a powerful movement and advancement because it encouraged more people to use the Accredited Persons program, thus the FDA was able to provide a more professional and sleek service to their customers.