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  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Biocompatibility Assessment Resource Center
  1. Premarket Submissions: Selecting and Preparing the Correct Submission

Biocompatibility Assessment Resource Center

Update: September 19, 2024

The FDA issued the draft guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices. This draft guidance, once finalized, is intended to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The draft guidance is also intended to improve consistency and reliability of analytical chemistry studies submitted as part of premarket submissions to demonstrate device biocompatibility.

Submit comments under docket number FDA-2024-D-4165 at www.regulations.gov by November 18, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

These resource pages are intended to explain terms and concepts important for the evaluation of biocompatibility of medical devices. It is not intended to replace any policies specified in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," also referred to as the FDA’s Biocompatibility Guidance on Use of ISO 10993-1, or other related guidance.

The FDA recommends that you:

 

Step 1

Biocompatibility Basics

Basics of Biocompatibility

  • When biocompatibility info is needed
  • What the FDA assesses or evaluates
  • How the FDA assesses or evaluates biocompatibility
  • Biocompatibility factors of interest to the FDA

Glossary of Biocompatibility Terms 

 

Step 2

Evaluation Endpoints

Biocompatibility Evaluation Endpoint Tables

By Device Category  By Contact Duration
 

 

Step 3

Test Articles

Documenting How a Test Article Compares to the Proposed Medical Device

  • Component documentation
  • Device documentation
  • New processing/sterilization changes
  • Formulation changes
 

Step 4

Test Report

What Should I Put in a Test Report?

  • Test reports
  • Test article preparation
  • Test parameters and acceptance criteria
  • Analysis of results
  • Conclusions
 

For device- and/or submission-specific biocompatibility questions, you may submit a pre-submission, as described in the Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program guidance.

For general biocompatibility questions, you may email CDRH.Biocomp@fda.hhs.gov.



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