Welcome to the Straight Talk with Susan Series

Welcome to Straight Talk with Susan: An Overview of the Regulatory Process for Medical Technology

Dr. Susan Alpert, MD, is one of the nation’s foremost experts on medical technology regulation. As a physician, former director of FDA’s Office of Device Evaluation, and former industry executive, Susan understands the medtech innovation ecosystem from all angles. Her unique perspective and decades of experience make her the ideal person to explain the complexities of medical technology development and regulation and the need to ensure that any requirements promote both patient safety and innovation.

In the U.S., FDA oversight of medical technology is often misunderstood. The range of medical devices, risk/benefit considerations, premarket evidence requirements and post-market monitoring are just some of the issues that have caused confusion.

It’s important that patients, health care providers, legislators, manufacturers and other stakeholders share a common understanding of these issues in order to achieve our shared goal or providing safe and effective new treatments to patient in a timely fashion.

Each week on the blog, Susan will dive into a different issue involving FDA’s regulatory framework for medical technology.

You can watch the entire Straight Talk with Susan video series on the AdvaMed YouTube channel. But make sure to check the blog each week for up-to-date analysis.

For additional resources, visit safety.advamed.org.

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