FDA developed this draft guidance to propose select updates to FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for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within a risk management process,’” (2016 Biocompatibility Guidance) remains in effect, in its current form, until this draft guidance is finalized.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 referenced below 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add or supersede applicable sections of the 2016 Biocompatibility Guidance after FDA considers public comment to this draft guidance.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.
For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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