Last month, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced the new electronic Biocompatibility Assessment Resource Center. The website is intended to provide guidance for evaluating the biocompatibility of Medical Devices in order to manage more easily the ISO 10993-1 requirements.
This resource aligns with the recommendations established in Use of International Standard ISO 10993-1, “Biological evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process” published in September 2020 by the FDA.
Guide for Biocompatibility Evaluation
These resource pages are intended to explain terms and concepts important for the evaluation of biocompatibility of Medical Devices.
The information contained in the website is not intended to replace any policies specified in ISO 10993-1 standard or the FDA guidance. It rather aims to help Medical Devices Manufacturers select the most appropriate tests to evaluate the adverse biological responses to Medical Devices.
This guidance outlines four steps for device Manufacturers to follow:
- “Biocompatibility Basics”, that provides basic information on biocompatibility and a glossary of biocompatibility terms.
- “Evaluation Endpoints”, that supplies biocompatibility evaluation endpoint tables by device category.
- “Test Articles”, that provides examples of documenting test article comparisons to proposed devices.
- “Test Report”, which includes the recommended contents of a test report.
FDA recommends the use of the Q-Submission program to submit specific question on biocompatibility evaluation.
How can Thema help you?
Through our wide range of strategic regulatory consulting services, our team of experts is available to provide you with further information and support during the phase of biological safety evaluation of devices.
Please contact us sending an e-mail to sales@thema-med.com
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