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
  • Unpacking the FDA’s Draft Guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
• 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)
  • Preparing for Stage 1 requirements under LDT Final Rule (taking effect early 2026)
• Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
• Utilizing companion diagnostics via smart technologies