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