US Regulatory Essentials for Devices and IVDs

A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (US) examination. Laws and policies affecting US regulation of devices and IVDs; an overview of the agency structures regulating these products; advertising, labeling and promotional aspects; and post-market, compliance and enforcement requirements will be covered.

Agenda:

8:30 - 8:45 am Welcome and Workshop

Overview: FDA History, FDA Organization, DICE Role, David Chadwick, PhD, RAC, FRAPS
8:45 - 10:30 am Overview of Medical Devices and IVDs: Classification, 513(g) and de novo, PMA perspectives, IDE and HDE perspectives, Clinical
conduct perspectives, Tony Blank, Atricure
10:30 - 11:00 am Coffee Break
11:00 am - 12:30 pm Overview of Medical Devices and IVDs, continued: Group 1: General Medical Devices, Tony Blank, Atricure; Group 2 IVD-focused
specific, Christie Hughes, Qserve
12:30 - 1:30 pm Lunch
1:30 - 2:15 pm QSR/WMS and Design Control, Etienne Nichols, Greenlight Guru
2:15 - 2:45 pm Post-market Compliance is no Easy Journey: Complaint handling and management, Understanding medical device reporting,
Corrections/Removals (recalls), Larry Pool, Cook Incorporated (remote)
2:45 - 3:15 pm FDA Inspections and Aftermath, David Chadwick, PhD, RAC, FRAPS
3:15 - 4:00 pm Advertising, Promotion and Labeling, Mark DuVal, DuVall & Associates
4:00 pm Wrap-Up