Biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. This webinar will cover the FDA's existing and recently updated draft guidance on the use of ISO-10993 to determine what testing is necessary, and describe in detail general and specific testing considerations, based on the nature and duration of contact of the medical device with humans. It will also cover when animal safety studies may be used to justify omission of certain biocompatibility tests, as well as the desired content of a biocompatibility test report.
Why should you Attend:
You should attend because biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. Therefore, it is important to know how to use the available FDA guidance to determine which tests listed in ISO-10993 will be required based on the nature and duration of contact of the medical device with humans. It is also important to know and understand specific details regarding how testing should be conducted in order to meet FDA's expectations.
Areas Covered in the Session:
History and background of biocompatibility testing and ISO-10993
Previous FDA guidance
Current FDA draft guidance
General testing considerations
Specific testing considerations
Use of animal safety studies to justify omission of specific biocompatibility tests
Assessment of known and/or potentially toxic chemical entities
Contents of a biocompatibility test report
Who Will Benefit:
Regulatory affairs professionals
Research and Development
Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.
Prior to joining CardioMed, Dr. Harvey worked for more than ten years in FDA’s Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health.
Event Link - http://bit.ly/1ioANb3