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

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

Evan Phelps
Partner
Amin Talati Wasserman LLP (Washington, DC)
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