Free webinar – 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
Date: December 16, 2020 | 3.00 PM - 4.00 PM CET | 4.00 PM - 5.00 PM Israeli Time Zone
Free Online Webinar: Attendance will be confirmed from the event's organizers
Attendees capacity: 100 delegates
INTRODUCTION:
FDA just revised this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.
The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1:2009, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” to support applications to FDA. This guidance document also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation.
TOPICS:
- Use of risk assessments for biocompatibility evaluations for a proposed medical device
- Use of FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints for an evaluation in relation with ISO 10993-1:2018
- General biocompatibility testing considerations, including test article preparation
- Considerations for testing procedures
- FDA approach to the chemical characterization and consensus standard
WHO SHOULD ATTEND:
- Regulatory affairs & QA experts
- Research, design & manufacturing engineers
- Experts involved in the evaluation of Medical Devices
- Product Managers & Laboratory Managers
- Process development & system engineers
- Toxicologists & biological safety experts
EVENT KEY NOTE SPEAKER:
Paolo Pescio, ERT
- 15+ years of experience with medical devices
- European Registered Toxicologist (ERT)
- HAS consultant
Expertise area:
- Toxicological evaluation and risk assessment
- Biological evaluation of medical devices
- Integrated Testing Strategies
Official Language: English
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