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

Mar 18, 2025 1:30 pm – 4:30 pm

Jennifer D. Newberger
Director
Hyman, Phelps, & McNamara, P.C.

Rachel Turow
Of Counsel, FDA Regulatory
Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates

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    • Unpacking the FDA’s Draft Guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products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