The FDA Medical Device Industry Coalition (FMDIC) is hosting a "Medical Devices 101" session on August 13. The event is tailored for folks with little experience with FDA, medical device manufacturers, specification developers, initial distributors of imported devices, entrepreneurs, very small start-up companies, new hires, students planning a career in the medical device industry or enforcement, and administrative and marketing employees. Click here to learn more.
Basic regulatory requirements are discussed: establishment registration, Listing, Premarket Notification 510(k), unless exempt, (PMA), Investigational Device Exemption (IDE) - clinical studies, Quality System (QS) regulation, Labeling, Medical Device Reporting (MDR)
Speakers include: Al Alonso (Industry), Dr. John Criscione (Academic - Texas A&M), and Jeff Wooley (FDA)
For more information and registration, please visit: https://s01.123signup.com/servlet/SignUpMember?PG=1521023182300&P=15210231911432302900&Info