The Accredited Persons Program was created by the FDA to meet the high demand of 510(k) submissions. The program is designed to coincide and work hand in hand with the FDA in order to provide a timelier and efficient service to customers. After all, people want their devices to hit the market as soon as possible and often this cannot be achieved due to the long waiting period of 510(k) results. If you want to avoid all of the extra fuss that comes with submitting a FDA 510k clearance submission, you may wish to submit via FDA Third Party Review. This is a perfect example of an Accredited Persons who will be able to fast track your 510(k) submission to the finish line. To prove just how useful a third party review program can be, we have included 7 of their best advantages below:
The most prominent advantage of this method of 510(k) submission is the fast timeliness of the reviewing process. In comparison to the FDA, an Accredited Person can have your initial review and finalised decision from the FDA back to you a lot faster than any other organisation.
- Competitive Costs
Instead of opting for the first alternative review company you can find, you have the ability to compare prices before making you final decision. Ask companies for estimated price quotes and take note before choosing the one that is right for you.
- Efficiency and Flexibility
Accredited Persons, unlike the official FDA, are very flexible and able to provide you with an efficient and effective service without any unnecessary hassle. For the easy 510(k) route, choose a third party reviewer.
- Experienced Reviewers
You 510(k) will be reviewed by professional experts in the field. They will closely analyse, assess and review your submission before sending off their findings to the FDA for a final decision.
- High Quality of Service
The FDA has ensured that each Accredited Person program or company deliver high quality services to each of their customers.
- Workflow Methodology
The reviewing process is able to run so smoothly and fast because of the fascinating workflow methodology commonly seen and practiced by such companies. You can rest easy knowing your 510(k) is in expert hands.
- Eliminates your need to pay FDA User Fee
When you apply directly to the FDA, you will more than likely be required to pay a user fee. This can be quite expensive, but when you submit your 510(k) to a third party reviewer, this fee is not needed and therefore, you save not only time when you choose this easier route, but money as well.