Regulatory Pathways: 361, Biologic, or Device?
The regulatory pathway for tissues is changing. What pathway is right for your allograft? In this session, we will review the pathway, limitations, criteria and process for reaching various regulatory classifications.
Melissa Greenwald, MD
Melissa Greenwald, MD is an internationally recognized expert in cell, organ and tissue safety and policy. Dr. Greenwald is a graduate of the Uniformed Services University School of Medicine who spent 25 years on active duty in the US Public Health Service with over 14 years at the U.S. Food and Drug Administration regulating human tissues for transplantation. Dr. Greenwald also spent four years at the Health Resources and Services Administration where she retired as the Director of the Division of Transplantation. Dr. Greenwald now directs her own consulting business specializing on safety management and regulatory affairs for cell, organ and tissue products. Dr. Greenwald serves the tissue banking industry in various roles, including Medical Director, Scientific Advisor, and Regulatory Affairs. She serves on the AATB standards committee as a representative of the Physicians Council.