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US FDA published today a draft guidance that it proposes will replace and extend G95-1, their key guidance on application of the ISO 10993 standard series to establish biocompatibility.
My view is that this is likely to be important to many of us that are involved in the design and/or marketing of patient contact medical devices.
http://www.fda.gov/downloads/Medica...nceDocuments/UCM348890.pdf?source=govdelivery
My view is that this is likely to be important to many of us that are involved in the design and/or marketing of patient contact medical devices.
http://www.fda.gov/downloads/Medica...nceDocuments/UCM348890.pdf?source=govdelivery