Preclinical Testing Issues Developing Combinations Products – Drug or Device Pathway?
February 21, 2019 @ 11:00 am - 12:00 pm
Approximately one-third of all medical products developed today are combination products. These devices require a unique approach when applying for regulatory approval.
In this hour-long webinar, Michael Dellogono, Ph.D., will discuss how to select the correct testing pathway and what regulatory requirements your device must meet – helping you reduce the time and stress involved with developing a preclinical testing program.
During this presentation he will review:
- Is your product a Drug or Device in the eyes of regulatory agencies?
- The blending of the biocompatibility & pharmaceutical pathways
- An overview of the biocompatibility requirements for combination devices
- The array of safety toxicology studies needed for all the materials in your product