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Polymer/Material Specifications - Class 1 Medical Device

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  Post Number #1  
Old 24th May 2008, 11:06 PM
veron

 
 
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Question Polymer/Material Specifications - Class 1 Medical Device

Hi,

I would like to check if FDA have any regulations stating that plastic polymer (no blood contact and only skin contact for a very brief time) used in Class 1 medical device requires to be of FDA approved grade.

Appreciate your help. thanx:

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  Post Number #2  
Old 26th May 2008, 10:17 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,690
Re: Polymer/Material Specifications - Class 1 Medical Device

Quote:
In Reply to Parent Post by veron View Post

Hi,

I would like to check if FDA have any regulations stating that plastic polymer (no blood contact and only skin contact for a very brief time) used in Class 1 medical device requires to be of FDA approved grade.

Appreciate your help. thanx:
You'll find your answer at
Guidance for Industry and FDA Reviewers - Immunotoxicity Testing Guidance
Thank You to Al Rosen for your informative Post and/or Attachment!
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