ASME is conducting a series of webinars to examine a risk-based, conceptual framework developed by the US Food and Drug Administration (FDA) for use at point-of-care manufacturing facilities. Webinar panels will include speakers from diverse groups, including medical device manufacturers, point-of-care manufacturers, technology developers, and the FDA. The framework includes the following scenarios:
A. Minimal Risk 3DP by Healthcare Professional
B&C. Device Designed by Manufacturer Using Validated Process
D. Manufacturer Co-Located at Point of Care
E. Healthcare Facility Becomes a Manufacturer
This webinar will take a deeper examination of Scenario A: Minimal Risk 3D Printing by Healthcare Professional.
Applications falling within the “minimal risk” classification include
Questions to be addressed by the panel include:
If you wish to view the FDA's Concept Framework Overview, and the slides from the Introduction to FDA's Regulation of Medical Devices, please visit the 3D Printing at the Point of Care website.