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GUIDANCE DOCUMENT

Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff September 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-4165

Docket Number:
FDA-2024-D-4165
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices.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.

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