Class 1 Medical Device ECR (Engineering Change Request) Changes

[Jkc3usc12]

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

 

[Jkc3usc12]

Thoughts?

 

[shimonv]

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

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

Shimon

 

[Jkc3usc12]

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

 

[shimonv]

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

Shimon