Adding information to Labels - Class II Medical Devices

[Core6505]

We sell a class II medical device, and we already cleared our 510k. However, after our submission, we conducted further testing and would like to put those testing results on our labeling (whether it be on website or product inserts). We aren't modifying the actual product, but rather providing more data to it. Other than our side at the design control, I was wonder what steps we must take to insure we don't get in trouble with FDA or regulations.

Our product detects a certain level of analyte, and we just want to show data of what happens or accuracy when you try to detect them at an earlier stage without claiming we have detection over those stages.

 

[Ronen E]

We sell a class II medical device, and we already cleared our 510k. However, after our submission, we conducted further testing and would like to put those testing results on our labeling (whether it be on website or product inserts). We aren't modifying the actual product, but rather providing more data to it. Other than our side at the design control, I was wonder what steps we must take to insure we don't get in trouble with FDA or regulations.

Our product detects a certain level of analyte, and we just want to show data of what happens or accuracy when you try to detect them at an earlier stage without claiming we have detection over those stages.

Hello and welcome to the Cove

In general labeling changes are considered device changes (and what you plan is considered a labeling change).

Evaluate the labeling changes you intend to implement, to decide whether they warrant a new 510(k) submission - there is a new draft guidance issued by the FDA on that, not long ago. If you conclude that the changes do not necessitate a new submission, you could document it (including reasoning) in a letter to file and be done with it. If the FDA asks questions in the future, show them the letter to file record.

If you want to avoid a new submission, make sure to be very clear about NOT making any addirtional claims over those included in your original 510(k).

Cheers,
Ronen.