The Food and Drug Administration (FDA) has announced that it will hold a public workshop entitled ASTM International-FDA Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance.
FDA is co-sponsoring the workshop together with ASTM International, an organisation responsible for the development and delivery of international voluntary consensus standards for engineered products, including medical devices. The purpose of the workshop is to provide a forum for highlighting and discussing the use of absorbable materials in medical devices across a broad range of indications with the aim of defining successful and unsuccessful methods to predict clinical performance. The main topics to be discussed include identification of test methods for establishing correlations between in vitro and in vivo degradation of absorbable implant devices, and the interaction of mechanical loading and mechanical performance with degradation. While there will be an emphasis on cardiovascular indications as part of a panel session, characterisation techniques and experiences from both cardiovascular as well as non-cardiovascular devices will be discussed and are encouraged.
The workshop will be held on November 28, 2012, from 8:30 a.m. to 5 p.m. EST at the FDA's White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD, 20993-0002, USA.
To register for the public workshop, please visit the FDA's Medical Devices News & Events--Workshops & Conferences calendar and select this public workshop from the posted events list.
Image courtesy of Swiss producer of resorbable polymers Degradable Solutions.