Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period

摘要

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of September 20, 2024. In the notice, FDA requested comments on the draft guidance for industry and FDA staff entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.