Regulatory Education for Industry (REdI) Annual Conference 2024: Devices Track

The devices track will provide an overview and highlights of how to get a new medical device to market, discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market and provide some technical topic updates on the use of clinical data and standards in regulatory submissions.

TOPICS INCLUDE

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

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.

FDA RESOURCES

• FDA’s Division of Industry and Consumer Education (DICE)
  www.fda.gov/DICE
  https://www.youtube.com/watch?v=yWYlO_4D4h4
• Device Advice:www.fda.gov/DeviceAdvice
• CDRH Learn:www.fda.gov/training-and-continuing-education/cdrh-learn