The FDA created the Accredited Persons Program with the intention to lessen the workload and hasten the 510(k) submission review timeline. More often than not, submitting to one of these third party 510(k) reviewers results in faster response times from the FDA themselves.

5 Advantages of Using a FDA Third Party Reviewer

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Here are 5 reasons why you should choose an Accredited Persons to review your 510(k) submission:

  1. Speedy Service

In comparison to the FDA, an accredited persons company such as will be able to review your FDA 510k clearance submission and save you approximately 100 days in the reviewing process. This is incredibly important for businesses because many need to clear their medical devices as soon as possible and applying directly to the FDA usually results in lengthy waiting periods.

  1. Competitive Costs

Before jumping on board with the first accredited persons that you approach, it may be worth comparing prices by obtaining different quotes beforehand. This gives you space to take a step back and make a decision that is right for you and your budget.

  1. Experienced Reviewers

Many third party reviewers for the FDA have experienced reviewers in their staff that have been specially trained by FDA to provide accurate and top quality services. This means that you can rest easy knowing that your application is in the hands of an experienced reviewer who will be able to properly assess and analyse your submission.

  1. High Quality Services

Accredited Persons display a better quality of service in terms of efficiency, timeliness and flexibility. Their workflow methodology usually involves a dedicated work force that are all too willing to help and assist you in whatever way they can. You will notice that there is a more open approach to communication between staff and yourself, allowing you to keep up to date with your 510(k) reviewing process.

  1. Trustworthy and Credible

Accredited Persons have been handpicked by FDA themselves and deemed fit enough to carry out such submissions and device reviews. This means that you can put your whole trust into the company, knowing that you will be experiencing the same level of professionalism and expertise as those supplied by the FDA. The only main difference between a third party review program and the FDA is the faster response times and quicker 510(k) reviewing rate.