New Perspectives in Wound Care Devices: Preclinical, Clinical and Regulatory Considerations

This webcast will discuss some of the regulatory issues and challenges posed by innovative wound care devices. Recent US Food and Drug Administration (FDA) guidance documents will be described with an emphasis on how the recommendations in the guidance may best be addressed. Attendees will gain an understanding of how these recent guidance documents and other FDA decisions impact the regulatory strategy and preclinical and clinical testing for new wound care devices.

As the long-time former chief of the Plastic and Reconstructive Surgery Devices branch at FDA, speaker Stephen Rhodes is in a unique position to offer insight into the agency’s testing requirements and decision making for wound care devices. Similarly, speaker Miriam Provost has many years of FDA experience, including serving as deputy division director for Plastic Surgery Devices and deputy ODE director in charge of combination product policy development. Together, the speakers’ insider knowledge of FDA’s thinking will provide valuable insight to anyone with an interest in wound care devices.