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Relevant questions on Substantial Change Form

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#1
We are adding in house manufacturing and we are submitting a substantial change form for our NB for CE/MDD/MDR.

In the document it asks Does the product incorporate SaMD or COTS Yes No If “Yes” Have the requirements of FDA Guidance on cybersecurity been applied Yes No Version of Guidance :

I am trying to claim this is not relevant to our changes. Am I correct? How would you respond?
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#3
Asked and answered and approved in our initial submission. Regardless, We submitted and had or Tech File approved. We are completing a substantial change form for something 100% unrelated to this. This feel like a lazy dragnet from our NB. We should not have to rejustify our technical file for something unrelated.
 

yodon

Staff member
Super Moderator
#4
What's as curious is why they would be asking about compliance to an FDA guidance when considering CE impact,
 
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