Class 1 Medical Device ECR (Engineering Change Request) Changes

J

Jkc3usc12

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#1
#1
Class 1 device not requiring a 510k still be reviewed by regulatory per 878.9 for engineering change request? I would be using document k97-1 for guidance and documentation.

Thanks
 
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shimonv

shimonv

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#3
#3
Jkc3usc12 said:
Class 1 device not requiring a 510k still be reviewed by regulatory per 878.9 for engineering change request? I would be using document k97-1 for guidance and documentation.

Thanks
Click to expand...
Hi Jkc3usc12,
Not every engineering change requires premarket notification; only significant changes as specified in 21 CFR 878.9(a,b, or c).

Shimon
 
J

Jkc3usc12

Involved In Discussions
#4
#4
Correct Im just wondering if there should be any type of documentation showing the changes made would not require notification.
 
shimonv

shimonv

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#5
#5
yes, your engineering change should contain a regulatory assessment based on the applicable regulation.

Shimon
 
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