This webinar will consider the Final Guidance on the use of ISO 10993-1 and ISO 14971 to perform risk-based biocompatibility studies on medical devices seeking marketing permission from the FDA for sales in the US.

 Areas to be discussed:

• Use of risk assessments for biocompatibility evaluations for a proposed medical device.
• Use of ISO 10993-1 and the FDA-modified matrix to determine the relevant biocompatibility endpoints for an evaluation.
• General biocompatibility testing considerations, including test article preparation.
• General considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments.
• Consideration of chemical assessment recommendations.
• Considerations for labeling devices as “-free.”  The preparation of test samples for ISO 10993 tests will be evaluated.

Areas Covered:-

• The Current ISO 14971:2019 for Devices
• ICH Q9 for Pharma
• ISO 10993-series
• Specific requirements of ISO 10993-1 
• The ISO 10993-1 Matrix
• Guidance from the EU MDR
• Specific US FDA Expectations from ISO 10993-1

Background:-

Use of ISO 10993-1 and ISO 14971 to perform medical device biocompatibility studies per the US FDA's guidance on risk-based biological evaluations.

Why Should You Attend:-

The US FDA's Final Guidance Document: “Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process“, Guidance for Industry and Food and Drug Administration Staff, issued September 8, 2023, outlines the Agency's expectations for the biological evaluations/tests to be conducted on submissions for device marketing in the US (510(k), PMA, De Novo, IDE ...).

This guidance was developed to assist in preparing submissions to the FDA for devices that come into direct or indirect contact with the human body.
It uses risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials. 

This guidance considers the assessment of biocompatibility to be an evaluation of the medical device in its final finished form, including sterilization, if applicable. However, sponsors should understand the biocompatibility of each device component and any interactions between components that could occur.

Who Should Attend:-

• Senior management in Drugs, Devices, Biologics, Dietary Supplements 
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Consultants; others tasked with project leadership responsibilities