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Introduction

Areas Covered in the Session:
Understanding the scope of the pre-submission process
What information to provide in a pre-submission
How to prepare for a pre-submission interaction with FDA
How to follow up with FDA following a pre-submission interaction

Useful links

Speakers

• Adam Fleming Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.
  Prior to joining CardioMed, Dr. Harvey worked for more than ten years in FDA’s Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health. She began as a reviewer in the Obstetrics and Gynecology Devices Branch. Later she became Chief of the Peripheral Vascular Devices Branch with the Division of Cardiovascular Devices. In this position she oversaw the review and approval of a wide variety of devices including peripheral and carotid stents, vena cava filters, stent-grafts for the treatment of thoracic and abdominal aortic aneurysms, and numerous other catheter-based technologies. Her most recent position at FDA was overseeing the Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) Programs in ODE. Here she directed regulatory policy for IDEs and HDEs, and managed ODE’s growing pre-IDE program, which has become an invaluable part of the device development plan. , United States

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Venue

Online Webinar

Online Webinar, 161 Mission Falls Lane, Fremont, 94539, United States

Contact information

Adam Fleming
Compliance4all
161 Mission Falls Lane
Suite 216 Fremont CA USA 94539
8004479407
Contact us by email

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