New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility
FDA Law Blog
NOVEMBER 20, 2024
That is, the biocompatibility endpoints cytotoxicity, sensitization, irritation/intracutaneous reactivity, material-mediate pyrogenicity, implantation, and hemocompatibility are not covered by the approach discussed in the new draft guidance. By Adrienne R.
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