Workshop B – Introduction to Medical Devices, Combination Products, Companion Diagnostics, and Medical Apps: A Review of FDA Guidelines and Regulations

Sep 17, 2019 1:30pm - 5:00pm



Stephanie Philbin
Goodwin Procter LLP (Washington, D.C.)

What is it about?

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 and the lab work necessary to display
  • Discussing key regulatory requirements, information, and concepts
  • Reviewing the FDA approval process for self-diagnosing devices
  • Exploring the FDA’s role in Clinical Laboratory Improvement Amendments (CLIA)
  • How does this impact the home use of a product?
  • What waivers are available?


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
  • Discussing the role of artificial intelligence and machine learning in combination products


Companion Diagnostics

  • Reviewing the software validation required for 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
  • When does a smartphone app require medical device clearance when doesn’t it?
  • Implementing methods to display data integrity