Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Chemistry, Manufacturing, And Controls (CMC), Premarket
Published
September 20, 2024
Last updated
September 19, 2024
Description
A draft guidance document by the FDA and industry on chemical analysis for assessing biocompatibility of medical devices, covering CMC and premarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)