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[FDA News] Regulatory Education for Industry (REdI) Annual Conference 2023

The FDA will be hosting the Regulatory Education for Industry (REdI) Annual Conference 2023 free of charge.

  • Date: June 5(Mon) – June 9(Fri), 2023

  • Time: 8:40 AM - 4:30 PM ET

<Registration Link>

This conference is divided into three tracks: Drugs, Medical Devices, and Biologics. It aims to provide an understanding of regulatory requirements emphasized by the FDA to promote and protect public health, as well as how the FDA advances programs through user fee support.

In particular, the Medical Devices track is expected to be beneficial for medical device company representatives and researchers who are seeking to get a new medical device to the market.

Devices Track

Topics Include

  • Artificial Intelligence and Machine Learning; FDA Medical Device Inspections & Form FDA 483

  • Premarket Notification [510(k)] Program; Quality System Principles

  • Tips and Best Practices for High-Quality Regulatory Submissions

Intended Audience

  • A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with the 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 its regulatory responsibilities for handling complaints about its medical devices.

For more detailed information, please refer to the following link.

We will streamline the regulatory processes so that our clients can utilize

their time and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have any questions about FDA regulation of OTC Drugs and Cosmetics,

Registration and labeling compliance..., please CONTACT US.

Office 1-909-493-3276


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