Regulatory Change assessment

MDRexpert

Involved In Discussions
#1
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!
 
Elsmar Forum Sponsor
#2
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…
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
We created a checklist from the FDA and EU MDD/MDR guidance we complete on major design changes.
 
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