Workshop B — Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

Mar 2021

Neil O’Flaherty
Partner
Amin Talati Wasserman LLP (Chicago, IL)

This workshop will provide an introduction and in-depth overview of medical devices, combination products, and companion diagnostics as well as the FDA regulations which govern these products.

Topics of discussion will include:

Medical Devices

  • Reviewing the history of FDA device regulations
  • Examining the basics of device classification and the FDA’s review process
  • Analyzing the clinical trials process for medical devices
  • Assessing strategies to obtain clinical data
  • Determining premarket approvals
  • Exploring the 510(k) clearance process
  • Discussing key regulatory requirements, information, and concepts

Combination Products

  • Defining the requirements for combination product classification and approval
  • Selecting the proper regulatory pathway
  • Exploring the Request for designation (RFD) process and the newly-created pre-RFD process
  • Determining the role of the Combination Product Policy Council and agencies regulating combination products
  • Examining existing cGMP’s for combination products

Companion Diagnostics

  • Exploring the regulations of laboratory developed tests (LDTs)
  • Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
  • Utilizing companion diagnostics via smart technologies