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Session 7: Digital Health Combination Products: What’s Next?
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
Nathan Brown, JD
Health Care and Life Sciences Partner
Akin Gump Strauss Hauer & Feld LLP, United States
While FDA regulation of digital health products has become increasingly clear for medical devices, the regulation of these products as combination products is still coming into focus. Especially for products that are not regulated at all as pure medical devices, once they are attached to a drug, the questions remain unanswered and the regulatory pathway is challenging to define. This session will give an update on many of the recent regulatory changes for digital health products and will seek answers to some of the more difficult regulatory questions through the use of hypotheticals.
Learning Objective :
Speaker(s)
21st Century Cures Act and Beyond — Implications for Digital Health
Nathan Brown, JD
Akin Gump Strauss Hauer & Feld LLP, United States
Health Care and Life Sciences Partner
Case Study – myBETAapp™
Resmi John
Bayer, United States
Associate Director, Regulatory Affairs
Speaker
Michael Koenig, MS
Bayer, United States
Group Head – Regulatory Affairs Established Products
View from the Top
Douglas C. Throckmorton, MD
FDA, United States
Deputy Center Director for Regulatory Programs CDER
Speaker
Linda Ricci
FDA/CDRH, United States
Associate Director, Office of Device Evaluation