Can We Work on our SaMD After Submitting our 510(k)?

 March 08, 2023


We talk through a strategy for speeding up 510(k) submissions by using a letter to file for certain features that wouldn't trigger the need for another 510(k). The amount of work done by the software engineering team should be the same (or higher) using this approach, but you can submit sooner, which can be a win if you have funding milestones or conferences deadlines tied to the submission.


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