Packaging and Label Change Requirements - ISO 13485/FDA 21CFR820

S

sturey45

#1
Hello Everyone,

This is in reference to mainly CFR 820.30 (i) relating to device changes. If there is a change made to packaging a or labelling, say we change just the look of the box, or use a different font or something like that is there any need to do some sort of process described in CFR 820.30 I? OR would we necessarily need to retain obsolete copies of the packaging?

What if we change care instructions, or markings related to regulatory requirements, something that could affect product quality we would have to have more stringent controls on those correct?:bonk:

Thanks,
Stuart
 
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M

MIREGMGR

#3
If there is a change made to packaging a or labelling, say we change just the look of the box, or use a different font or something like that is there any need to do some sort of process described in CFR 820.30 I?
Based on those limited facts, no as long as the change does not affect safety or effectiveness. Note however that if the original packaging qualification included an ISO11607 or similar packaging performance validation process to protect safety or effectiveness, then a change probably would require a similar re-validation.

OR would we necessarily need to retain obsolete copies of the packaging?
That would only be a requirement if the change is one that requires controls and isn't otherwise properly documented.

What if we change care instructions, or markings related to regulatory requirements, something that could affect product quality we would have to have more stringent controls on those correct?
Yes.
 
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