Class 1 Medical Device ECR (Engineering Change Request) Changes

J

Jkc3usc12

Involved In Discussions
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
 
shimonv

shimonv

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

shimonv

Trusted Information Resource
yes, your engineering change should contain a regulatory assessment based on the applicable regulation.

Shimon
 
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