Using the Pre-Submission Process to Your Best Advantage
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This webinar will provide a detailed discussion of 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 and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.
In this webinar we will discuss recent FDA observations in the laboratory and how this knowledge can be used in the laboratory to prevent or reduce regulatory observations in the future.
Why should you Attend: You should attend because using the pre-submission process is an increasingly essential and critical component of any US marketing application for a medical device. Therefore, it is important to know how to best use the pre-submission process to effectively obtain feedback from FDA's Office of Device Evaluation on proposed testing for any medical device to be commercialized in the US. Effective use of the pre-submission process will allow companies to know and understand FDA's expectations regarding their medical device before submitting a marketing application.
Areas Covered in the Session:
Who Will Benefit:
- 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
- Regulatory Affairs Professionals
- All companies developing manufacturing and marketing medical devices in the US
Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. She 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.
Dr. Harvey's diverse background includes basic and clinical research, and clinical veterinary experience. She has extensive experience in review and approval of preclinical animal protocols, feasibility and pivotal clinical study protocols, and optimizing pre-IDE packages in order to maximize the effectiveness of meeting with the Agency in the pre-IDE phase.
Prior to her work at FDA, Dr. Harvey practiced veterinary medicine full time for several years. She earned her Bachelor's degree in biology at Mary Washington College, her Master's and Ph.D. degrees in zoology and reproductive physiology respectively at the University of Connecticut, and her veterinary medical degree from Tufts University.