CPC Submits Comments on FDA’s Draft Guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin”

On December 14, 2020, the CPC submitted comments on FDA’s Draft Guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin” (the “Draft Guidance”). The CPC generally agrees with the concepts proposed in the Draft Guidance, and appreciates FDA’s recognition of the low risk posed by various common device materials that contact intact skin, but has identified areas of the document that would benefit from additional clarity. The CPC also recommends inclusion of combination products within the scope of the Draft Guidance.