FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard

M

Mark Meer

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The US FDA just released a new draft guidance: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.

I think it's a great update, that explicitly makes considerations for common materials such as ABS, PC, Cotton, Nylon, Silicone,...

From the (draft) guidance:
Many devices have intact skin contacting materials that are made from polymers and fabrics. 51 FDA believes that these materials pose a very low biocompatibility risk because they have a long 52 history of safe use in medical devices that contact intact skin. For such devices, significant FDA 53 review resources are expended to obtain sufficient rationales to justify omission of 54 biocompatibility testing for frequently used intact skin contacting medical devices, consistent 55 with FDA’s recommendations in the 2016 Biocompatibility Guidance.
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