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
Basics of biocompatibility:
Glossary of biocompatibility terms
Biocompatibility Evaluation Endpoint Tables:
Test Article - Documenting How a Test Article Compares to the Proposed Medical Device - read more
Test report - What Should I Put in a Test Report?
- Test reports
- Test article preparation
- Test parameters and acceptance criteria
- Analysis of results