FDA Vs Accredited Persons Program: Which is Faster for 510(k) Submission?


The FDA, otherwise known as the Food and Drug Administration, is responsible for ensuring the safety and effectiveness of both human and animal drugs. The federal agency is also accountable for guaranteeing the safety, security and efficacy of other biological products, cosmetics, medical devices, the nation’s supply of food and products that emit degrees of radiation, according to the official FDA website.

FDA Vs Accredited Persons Program

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The Accredited Persons Program is a program developed by the FDA to assist with the assessment of 510(k)’s. In accordance with the FDA Modernization Act of 1997 (FDAMA), the Accredited Persons program is in place to help improve both the efficiency and timeliness of the reviewing process of eligible devices for 510(k) submissions. But which option is faster?

FDA Timeline

The FDA embodies an average completion time of approximately 172 days, on average. This estimated time period begins from the moment the FDA receives your submission, right up until you receive the final decision at the end.

Since your 510(k) submission ends up here eventually, many people think they may as well just send it here from the very beginning. However, FDA takes a long time to not only assess your submission but to move it along the process in a timelier matter. This is most likely due to the fact that the FDA receives thousands of applications each year, resulting in a heavy back log of 510(k)’s that need approval or disapproval.

Accredited Persons Timeline

How long does it take to get a FDA 510k approved? With fdathirdpartyreview the timeline from beginning to end takes only 65 days on average. As you can see, that is over 100 days faster than applying directly to the FDA. The reason for this is because TPRG gets to work immediately upon receiving your 510(k) submission.

Choosing a third party review program such as this one will ensure that your 510(k) submission flies through the process in a more efficient time frame. Once the Accredited Persons have completed their initial review, your submission is then forwarded to the FDA. Once the FDA receives a 510(k) submission from an Accredited Person, they MUST complete the reviewing process within a 30-day deadline. This is the main reason why sending your 510(k) clearance submission to a third party reviewer provides faster results without having to wait around for an additional 100 days.

Written by suNCh8

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