Biocompatibility assessment of medical devices in 4 steps - FDA recommendations

Biological assessment or testing of the biocompatibility of medical devices is an essential part of conformity assessment. But how do I properly and efficiently assess the biocompatibility of my medical device? The FDA has published new recommendations for assessing the biocompatibility of medical devices.

Procedure for assessing the biocompatibility of a medical device:

• Read FDA biocompatibility guidance on the use of ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and "FDA’s Biocompatibility Guidance on Use of ISO 10993-1"
• Follow the steps listed on the following website: https://www.fda.gov/medical-devices/premarket-submissions/biocompatibility-assessment-resource-center

Step 1

Basics of biocompatibility:
Glossary of biocompatibility terms

Step 2

Biocompatibility Evaluation Endpoint Tables:

• by device category
• by contact duration

Step 3

Test Article - Documenting How a Test Article Compares to the Proposed Medical Device - read more

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