FDA draft the new guidance document "Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff"

The FDA released a draft guidance document titled "Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff" in September 2024. This draft is currently in circulation for feedback and comments. You can download from here:

FDA-2024-D-4165-0002_attachment_1.pdf

Download PDF • 974KB

You can submit your comments in the following link:

Regulations.gov