Has anyone here assessed the latest Abbreviated 510(K) guidance document?

M

MDRexpert

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#1
#1
A relatively new FDA abbreviated 510(K) guidance is published and I was wondering if anyone has assessed the gap analysis or created a summary report to state if the updated guidance is applicable to their QMS. Can you please share some ideas or scrubbed version? Thanks!
 
M

MDRexpert

Starting to get Involved
#2
#2
Can someone help me how this change will effect in "510K" procedures. I am updating our SOP's based on this update.
As well as "notification of changes to Regulatory agencies (EU/US) procedures.
 
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