FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track

May 29-30, 2024

Go to Drugs Track   –   Go to Biologics Track

About This Course

The Regulatory Education for Industry (REdI) Devices Track provides an overview and highlights of how to get a new medical device to market, discusses some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market and provides some technical topic updates on the use of clinical data and standards in regulatory submissions.

Intended Audience

• A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices.
• A researcher of a medical device seeking to learn about the valid scientific evidence requirements needed to support new medical device regulatory submissions.
• An establishment seeking to understand their regulatory responsibilities for maintaining their quality system to ensure their device is stay and effective after it’s legally marketed and in commercial distribution.

Topics Covered

• Regulatory Science Tools
• Premarket Notification [510(k)] Program
• Clinical Studies, including Investigational Device Exemptions
• Quality System Principles
• FDA Medical Device Inspections

Resources

• FDA’s Division of Industry and Consumer Education (DICE) www.fda.gov/DICE
  https://www.youtube.com/watch?v=yWYlO_4D4h4External Link Disclaimer
• Device Advice:www.fda.gov/DeviceAdvice
• CDRH Learn:www.fda.gov/training-and-continuing-education/cdrh-learn

visit the FDA.gov webpage