STP Joint SIG Webinar on Regulatory Considerations of Cardiovascular Medical Devices

When:  Apr 11, 2023 from 12:00 to 14:00 (ET)

STP Joint SIG Webinar
 
April 11, 2023 | 12:00 PM–2:00 PM EDT
Hosted by the Cardiovascular (CV) and Medical Devices (MD) Special Interest Groups
 
Speakers:


Fuyuan Wang, BVM, MS, PhD, DABT Toxicologist and Lead Reviewer, US FDA
 Natalie Miller, VMD, PhD
Veterinary Medical Officer/Animal Studies Reviewer, US FDA
  Nicole Kirchhof, DVM, DACVP
Medical Device Pathologist, Medtronic

Overview: 
This 2-hour virtual webinar includes two 20-min presentations by our invited FDA panelists and a 40-min presentation by our invited pathologist, followed by a 40 minutes Q&A discussion. As a joint venture between the cardiovascular and medical devices SIGs, this agenda will provide insight into the pathologic evaluation of medical devices used in cardiovascular diseases as well as the regulatory considerations for developing these devices.

Dr. Wang is a veterinary pathologist, toxicologist, and lead reviewer at the FDA with extensive experience in submissions for medical devices. He will bring his expertise to a general overview of medical device regulatory considerations.

Dr. Miller is a veterinary scientist with over 7 years experience at the FDA as a Veterinary Medical Officer. She has extensive involvement in animal study design and evaluation in the areas of cardiovascular devices. She will bring her expertise to a deeper dive into the regulatory perspectives unique to development of cardiovascular devices.

Dr. Kirchhof is a medical device and comparative pathologist with over 17 years of experience in the industry. She has had many opportunities to evaluate studies supporting development of cardiac and vascular medical devices and is well-versed in the unique pathologies and considerations characteristic of the field.
 Registration is required.