Questions You Should Ask Before Submitting Your 510(K)

Before submitting your 510(k) to either the FDA or an Accredited Person (third party reviewing organization), you should take some time to ask yourself important questions that may help hurry the process along.

Questions You Should Ask Before Submitting Your 510(K)

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Here are the 4 most important questions you should ask before finally submitting your 510(k):

  1. Accredited Persons Vs FDA: Which Should I Choose?

One of the first questions you should ask yourself is what route you would like to take with regards to submitting your 510(k). You have two options, to submit directly to the FDA or submit your application to a third party reviewer. The FDA tends to handle the more “higher risk” device applications whilst accredited persons can handle the low to moderate risk devices.

The FDA tends to take a long period of time to provide finalised results, often taking months to complete a review. However, an accredited person will hurry the process along and forward the final review to the FDA, who then have 30 days to finalise the process.

  1. Is my Device Eligible for 510(k)?

According to Device Watch, before submitting a 510(k), you must know whether or not your device is eligible. This is achieved by checking the product code of your product on the official FDA list of eligible devices. If you can’t find your device on the list, you may need to get in contact and do more research into the matter. If your product code is listed, then you have the go ahead to submit your 510(k).

  1. Which Accredited Person Should I Use?

If you have decided to go through the accredited person route to submit and forward your submission to the FDA, you need to decide which organization you would like to go with. This is up to personal preference, however, you can refer to the FDA list of accredited persons to assist you with the search for the most ideal accredited persons to assist and review your FDA 510k clearance submission. You may wish to stick with the most credited of the list, such as

  1. Should I seek More than one Price Quote?

Before finalising any payments, it is best to obtain a number of price quotes from more than one accredited persons. This will give you a better idea of how much it is going to cost for the submission of your device and you can then decide whether or not you are happy with the final cost or not.


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