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:

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 (http://www.fda.gov/cdrh/ost/ostggp/immunotox.html)