I am new to the forums, so this may have been asked and answered before, but I have seen a recent trend and am hoping for some input from those with more experience on this topic.

I work for a medical device manufacturer. We have always used polymers that are classified (by the manufacturer) as "Medical Grade". In the past, these materials had references to having met the requirements of USP Class VI on the technical data sheet. For a material we have been using for many years, that statement has now been removed. I have also seen "FDA Compliance" which generally seems to indicate food contact approval.

So, what is required for a material manufacturer to label a material as "Medical Grade"? Is there an industry standard or some other standard to which this claim must measure up? Are there additional requirements to stating USP Class VI compliance other than the biocompatibility tests listed in the USP - such as frequency of testing (each lot or annually), notification to users of changes in material formulation or process or raw material supplier, etc.??

Thank you in advance!