FDA 510(k): Premarket Submission

510(k): Pre-market notification

General information about the most important approval process of the FDA

In contrast to the European judicial area, the FDA has explicit approval for medical devices. The most prominent authorization procedure is named after an article in the Food, Drug and Cosmetic Act (FD&C): 510(k).

You can use this admission procedure if your product falls into class II and if there is a similar predecessor product, the so-called Predicate Device, which must be truly comparable: i.e. "substantially equivalent".

You will learn more about the 510(k) approval process of the FDA in the audit guarantor.

In this series of video tutorials you will learn:

  • which legal frameworks you must adhere to
  • when you need a 510(k) approval and when you don't
  • - and which changes may be necessary
  • which 510(k) options exist
  • what documents you need to submit in which form
  • how the procedure works as a whole.

The schedule is extensive:

510(k) in relation to Changes

It is a big discussion that a new 510(k) is not necessary in every software change. I personally agree to this statement.

FDA Clearance is necessary, only if there is a change in the intended use. Such changes in intended use may come up with new products and functions. 

What I mean with function is the functionality, not an actual function/method in the program. Changes are absolutely allowed under the condition that it does not require new 510(k) or at least allows a shortened version of 510(k).

Here are some articles I recommend regarding this topic:

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