Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

On 15 October 2020 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted until 15 December 2020.

FDA developed this draft guidance to propose select updates to FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. The existing guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,’” (2016 Biocompatibility Guidance) remains in effect, in its current form, until this draft guidance is finalized. The proposed sections are intended to add or supersede applicable sections of the 2016 Biocompatibility Guidance after FDA considers public comment to this draft guidance. The sections of the 2016 Biocompatibility Guidance that are not affected by this select update will not be substantively changed and will remain in effect.

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