Regulatory Change assessment

[MDRexpert]

We have flowcharts to identify regulatory assessment and we also refer to the guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device"?
Still a lot of times I'm perplexed with the challenges during assessing changes. Does someone have a simplified method to identify the changes and/or a flow chart for this?

Thanks!

 

[Harkey]

I’m not familiar with changes for 510k products but just wanted to comment that establishing internal guidelines for assessing changes can be challenging because pretty much every situation is different hahaha…

 

[monoj mon]

Have you checked the examples at the back of the guidance? I found those very helpful.

 

[Ed Panek]

We created a checklist from the FDA and EU MDD/MDR guidance we complete on major design changes.