Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 20, 2024
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Chemistry, Manufacturing, and Controls (CMC)
Status: Draft

Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This guidance applies to methods for analytical chemistry testing of medical devices generally. However, different methods may be needed for a particular medical device due to the materials used in the device or based on historically established approaches. Moreover, if there are device-specific FDA guidances or FDA-recognized consensus standards that address chemical analysis for a particular type of device, those recommendations should be followed. The recommendations in this guidance are intended to promote consistency and facilitate efficient review of analytical chemistry studies in medical device submissions.

Download the Guidance Document