Our technical and regulatory experts actively participated in the workshop and its biocompatibility round table discussion.
The Federal Drug Administration (FDA) continues to focus on an approach to reduce the burden on medical device manufacturers with the goal to expedite time to market without jeopardizing regulatory oversight related to product safety. The agency’s latest program, Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, was formed with this objective in mind.
At a public workshop held in May 2018, the FDA worked with leaders from the medical device industry, including those with intimate knowledge of testing standards, on the ASCA pilot program. The workshop included breakout sessions with one focusing on ISO 10993 biocompatibility for biological end point safety.
Subject matter experts, including WuXi AppTec Laboratory Testing Division’s Dr. Li Yang and Jean Kringstad, participated in the round table session.
Dr. Li Yang, Senior Scientific Director, supports our clients as part of our Consulting group. She provides global regulatory and technical preclinical safety support, is a board-certified toxicologist and has served as an FDA Commissioner’s fellow. With this unique dual perspective, she highlighted the importance of a program such as ASCA as well as how laboratory science and regulatory safety oversight may align in the future for the benefit of medical device manufacturers.
Jean Kringstad, Director of In-Vitro Testing Services, has more than 15 years of experience with ISO 10993 in-vitro studies. Jean articulated the scientific rational as well as the operational execution of these studies for the in-vitro assays proposed as part of the FDA ASCA pilot program.
At the conclusion of the workshop, our technical and regulatory experts returned with reinforced enthusiasm for this program. They look forward to continuing their involvement with the FDA as this pilot program aligns with WuXi AppTec’s continued focus on the science of biological safety.
For more information about how our experienced experts can work with you and your medical device testing, contact us.