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Renaissance Washington DC Dupont Circle Hotel

Oct 25, 2016 7:15 AM - Oct 26, 2016 3:30 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Combination Products 2016

Current, Evolving, and Future Pathways

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Session 6: Digital Health Technologies: Are They Combination Products? Does It Matter?

Session Chair(s)

Rachel Turow, JD, MPH

Rachel Turow, JD, MPH

Managing Counsel, FDA Regulatory

Walmart, Inc., United States

The application of digital technology to health care has exploded in recent years. FDA has made big strides in clarifying how certain digital technologies may be regulated as medical devices, but questions remain regarding digital health technologies that fall into the category of combination products. This panel will discuss the challenges of regulating digital health technologies that touch on both the drug and device paradigms, as well as the challenges of innovating in this space without a clear regulatory path or guidelines.

Speaker(s)

Zach Rothstein, JD

Moderator

Zach Rothstein, JD

Advamed, United States

Associate Vice President

Douglas C. Throckmorton, MD

Speaker

Douglas C. Throckmorton, MD

FDA, United States

Deputy Center Director for Regulatory Programs CDER

Bakul Patel, MBA, MS

Speaker

Bakul Patel, MBA, MS

Google Health, United States

Senior Director, Global Digital Health Strategy and Regulatory

Danelle R. Miller, JD

Speaker

Danelle R. Miller, JD

Roche Diagnostics, United States

Vice President, US Regulatory Policy and Intelligence

Rachel Turow, JD, MPH

Speaker

Rachel Turow, JD, MPH

Walmart, Inc., United States

Managing Counsel, FDA Regulatory

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